- Email: [email protected]
Benign biliary strictures: Repair and outcome with a contemporary approach
Benign biliary strictures: Repair and outcome with a contemporary approach Monica L. McDonald, MD, Michael B. Farnell, MD, David M. Nagorney, MD, Duane M. Ilstrup, MS, and Jill M. Kutch, BS, Rochester, Minn.
Background. The Hepp-Couinaud technique is an innovative approach for repair of proximal biliary strictures. We have used this method selectivelyfor bile duct reconstruction since 1982. Our aim was to analyze our experience with the surgical repah" of benign biliary strictures in the decade since the Hepp-Couinaud technique has become an integral component of our surgical management strategy. Methods. Seventy-two patients undergoing surgical repair of benign biliary stricture between 1983 and 1992 were reviewed retrospectively. A grading system on clinical symptoms, results of liver function studies, and need for reintervention was used to assess outcome. Results. For the 27 patients with noniatrogenic strictures, followed up a mean of 3. 9 years, excellent or good results (grade A or B) were obtained in 88.9%. For the 45 patients with iatrogenic strictures, followed up a mean of 4. 6 years, 86. 7 % were categorized as grade A or B. The cumulative probability of anastomotic failure was significantly lessfor the 21 patients in whom the Hepp-Couinaud method was used when compared with the 24 patients in whom it was not (p = O.032). Outcome was not influenced by age, time delay from injury to reconstruction, preoperative stenting, the number of previous repairs, or the duration of postoperative stenting. Conclusions. Surgical reconstruction affords excellent or good results for the vast majority of patients with benign biliary strictures. For proximal iatrogenic strictures superior anastomotic durability is achieved with the Hepp-Couinaud technique. (SURGERY1995;118:582-91.) From the Department of Surgery and Department of Health SciencesResearch, Mayo Clinic, Rochester, Minn.
ALTHOUGH BENIGN BILIARYSTRICTURES are caused by iatrogenic injury in most patients, inflammatory processes of the bile duct or adjacent organs may also result in ductal stricture. The technique of bile duct repair has become standard and consists of either duct-to-duct or biliary enteric anastomoses. In the last large series from our institution 1 the outcome of stricture repair in 265 patients with a m i n i m u m of 5 years of follow-up was satisfactory in only 61%. Interest in surgical repair of benign bile duct strictures has been rekindled by several developments. First, the advent of laparoscopic cholecystectomy has led to increased referral of patients requiting biliary reconstruction. Second, both endoscopic and percutaneous balloon dilatation and stenting have been advanced as alternatives to operation for both iatrogenic and inflammatory bile duct strictures. Third, an innovative surgical approach to proximal strictures of the extrahepatic biliary tree, the Hepp-Couinaud approach, 2 has facilitated the performance of a wide, muPresented at the Fifty-secondAnnual Meeting of the Central Surgical Association, Cleveland, Ohio, March 9-11, 1995. Reprint requests: Michael Farnell, MD, MayoClinic, 200 First St. SW, Rochester, MN 55905. Copyright 9 1995 by Mosby-YearBook, Inc. 0039-6060/95/$5.00 + 0 11/6/66623 582
SURGERY
cosa-to-mucosa anastomosis of pliable, well vascularized bile duct to gut. First described in 1956 in the French literature, the Hepp-Couinaud approach was popularized in Europe by Bismuth 3 and Blumgart et al4, 5 but has not been used widely in the United States. We became aware of this technique and began using the approach in our practice in 1982. Since that time we have increasingly used this approach, where applicable, for the management of proximal biliary strictures. O u r aim was to review our contemporary experience with the surgical repair of benign biliary strictures with specific reference to the Hepp-Couinaud method.
PATIENTS AND METHODS The records of patients undergoing operation for benign biliary stricture between 1983 and 1992 were reviewed. Malignant strictures or benign strictures associated with either sclerosing cholangitis or liver transplantation were excluded. The medical records w e r e reviewed with reference to cause, details of surgical management, hospital course, and outcome. Follow-up was obtained by review of records of subsequent visits and supplemented by p h o n e interviews with the patient and primary physician. The strictures were classified on the basis of radiologic and operative findings after the m e t h o d of Bismuth. 3
Surgery Volume 118, Number 4
McDonald et aL
Segment
i//.//,.
583
!1,2 3
cy, ic plate
Urob, ca, / ~ / ~:~o
A
u.,_. Hilar plate
plate
B Fig. 1. A, Left main hepatic duct, left main portal vein, and left hepatic artery are invested within a vasculobiliary sheath, the hilar plate, which consists of condensation of endoabdominal fascia. Note transverse orientation of left main hepatic duct at base of segment IV. Access to left main hepatic duct is gained by incising Glisson's capsule at base of segment IV and retracting segment IV cephalad. Vasculobiliary sheath is incised exposing origin of fight main hepatic duct, the confluens, and left main hepatic duct, B, Sagittal section of liver through segment IV, which shows extrahepatic and yet protected location of left main hepatic duct, anterior and superior to left main portal vein and left hepatic artery. Arrow indicates plane of dissection at base of segment IV to facilitate access to left main hepatic duct.
The Hepp-Couinaud technique was used for proximal iatrogenic biliary strictures on the basis of surgeon preference. The Hepp-Couinaud technique capitalizes on the rather long extrahepafic course of the left main hepatic duct nestled beneath the quadrate lobe (segm e n t IV). Although the left main hepatic duct is extrahepatic and can be accessed without the need for dissection of hepatic parenchyma, protection is afforded both by location beneath the base of the quadrate lobe and investment within a condensation of the endoabdominal fascia, the hilar plate (Fig. 1). Accord-
ingly, the left main hepatic duct is generally both uninvolved in most bile duct injuries that occur as a result of open or laparoscopic cholecystectomy and also unaffected by inflammation and infection attendant with bile leakage. Access to the left main hepatic duct is obtained by incising the peritoneum at the base of segment IV and retracting segment IV cephalad. Downward traction is applied to the hepatoduodenal ligament, and the hilar plate is incised over the anterior superiorly located left main hepatic duct, which courses transversely beneath the base of segment IV. A 2 to 3 cm
584
McDonald et al.
Surgery October 1995
/
-\
P F ~ MAYO
Fig. 2. Origin of right main hepatic duct, confluens, and left main hepatic duct have been exposed by incising Glisson's capsule at base of segment IV, retracting segment 1V cephalad and then incising vasculobiliary sheath overlying the proximal extrahepatic biliary system. Roux-en-Y loop has been carried through right transverse mesocolon in preparation for 2 to 3 cm side-to-side biliary enteric anastomosis. T a b l e I. Grading system used to evaluate outcome of patients undergoing operation for benign biliary stricture Grade A Grade B Grade C Grade D
Normal liver function test (LFT) results, asymptomatic Mild elevation LFT results, asymptomatic Abnormal LFT results, cholangitis, pain Surgical revision or dilation required
longitudinal incision is made in the left main hepatic duct, which facilitates a very wide-mouth, side-to-side, bile duct-to-jejunal anastomosis (Fig. 2). For those patients in whom the Hepp-Couinaud method was used,
the anastomosis was performed with a single layer of interrupted 4-0 absorbable suture. In most cases the anastomosis was splinted with a transhepatic, transanastomotic catheter (Fig. 3). Follow-up was obtained in all patients. To assess the durability of the repair, a grading system was devised on the basis of the patient's clinical symptoms, laboratory parameters, and the need for further intervention (Table I). Outcome was based on grade at the time of last follow-up. Those patients undergoing dilation or reoperation were censored from the analysis at the time of intervention. Statistical methods. Survivorship free of failure (the need for reoperation or dilatation) was estimated as a function of time from operation by using the KaplanMeier method. Ninety-five percent confidence intervals are presented on all survival curves. Comparisons of
Surgery Volume 118, Number 4
McDonald et al.
585
MAYO 9
Fig. 3. Side-to-side, left main hepaticojejunostomy. Transhepatic, transanastomotic locking catheter is placed before initiation of suture placement and used both to decompress biliary system during perioperative period and to allow postoperative radiographic imaging. Anterior layer of sutures is placed initially and secured sequentially in a spring keeper. Posterior layer is completed. Transanastomotic splint is then directed into limb of jejunum with side holes laying both above and below anastomosis. Lastly, anterior row of sutures is placed in the jejunum and tied (after method of Blumgart and Kelley).
individual survivorship curves, for example, between iatrogenic and noniatrogenic patients, were made with log-rank tests. The relationships between continuous variables such as age and time from injury to repair were investigated with the Cox proportional hazards model. Chi-squared tests were used to c o m p a r e proportions, and Wilcoxon rank-sum tests were used to compare ordinal results such as outcome. All significance tests were two-sided, and p values less than 0.05 were considered statistically significant.
T a b l e II. Bismuth classification of benign biliary strictures (N= 72)
I II III IV V
Iatrogenic (N = 45)
Noniatrogenic (N = 27)
13 18 7 5 2
22 3 1 1 --
RESULTS Between 1983 and 1992, 72 patients underwent opera t i o n for biliary stricture resulting from either iatrogenic or nonsurgically related causes. The 45 iatrogenic and 27 noniatrogenic strictures were classified by the Bismuth system (Table II). NonsurgicaUy related strictures. The majority of the 27 patients with nonsurgically related strictures were classified as Bismuth type I (Table II). The 18 m e n and 9 women had a mean age of 49.9 years (range, 22 to 84 years). The cause of the stricture was chronic pancreatitis in 14 (52%), unknown cause in 10 (37%), radiation in 2 (7%), and external blunt trauma in 1 (4%). Mean
duration of hospitalization was 12.5 days (range, 5 to 55 days). Mean duration of follow-up was 3.9 years (range, 3.2 to 11 years). Abdominal ultrasonography or abdominal c o m p u t e d tomography was used before operation most commonly. Endoscopic retrograde cholangiopancreatography (ERCP) was used diagnostically in 16 patients, percutaneous transhepatic cholangiography alone in two, and both in five, Neither investigation was obtained in four patients. The procedures used for managing the strictures are shown in Table III and reflect the fact that the majority were Bismuth type I; in some cases either concern regarding malignancy or in-
586
McDonald et al.
Surgery October 1995
Table III. Operative procedures used for benign biliary strictures (N= 72) Iat,vgenic Couinaud)* Noniatrogenic
Roux-en-Y hepaticojejunostomy Roux-en-Y choledochoj ej unostomy Hepaticoduodenostomy Choledochoduodenostomy Duct-to-duct anastomosis Whipple Cholecystoj ejunostomy, pancreaticoj ejunostomy Transduodenal sphincteroplasty Stricturoplasty TOTAL
Grade result Bismuth type
(HeppProcedure
Table V. Result as function of Bismuth classification
38 (19)
4
2 (1)
3
2 (1) 1 1 0 0
0 10 0 6 2
1 0 45 (21)
1 1 27
A
B
Iatrogenic strictures (N= 45) I 10 (2) 1 (0) II 12 (7) 4 (1) III 5 (5) 2 (1) IV 2 (2) 1 (1) V 2(1) 0(0) Overall 31 (17) 8 (3) Nonsurgically related strictures I 15 6 II 2 0 III 0 1 1V 0 0 Overall 17 7
C
D
0 (0) 2 (0) 1 (1) 1 (0) 0 (0) 0 (0) 0 (0) 2 (0) 0 ( 0 ) 0(0) 1 (1) 5 (0) (N= 27) 1 0 0 1 0 0 0 1 1 2
% A +B
84.6 88.9 100,0 60.0 100,0 87.7 (95.2) 95.5 66.7 100.0 0 88.9
Numbers in parentheses represent those patients with iatrogenic smctures in whom the Hepp-Couinaud technique was used.
*Numbers in parentheses denote those patients with iatrogenic stricture in whom Hepp-Couinaud method was used.
Table IV. Postoperative major complications in patients undergoing operation for benign biliary stricture latrogenic
Deep wound infection Superficial wound infection Intraabdominal abscess Bile peritonitis Intraperitoneal bleeding Acute pancreatitis Retained stone, intrahepatic duct Persistent pyrexia Anastomotic leak Septicemia ReoPeration for retained drain Pulmonary embolism Patients with major complications*
Noniatrogenic
1 2 5 1 1 1 1
1 2 1 0 2 1 0
2 1 1 2
2 l 0 0
0 16 (36%)
1 7 (26%)
*Some patients experienced more than one major complication.
tractable pain p r o m p t e d resection of the stricture. Transanastomotic stents were used in 10 patients for a mean of 24 days after operation (range, 14 to 153 days). Major morbidity occurred in seven patients (26%) (Table IV). Operative death occurred in one patient with a Bismuth type IVstricture. That patient underwent resection of the stricture with a double hepaticojejunostomy, experienced intraperitoneal hemorrhage after operation requiring reoperafion, and died approximately 1 m o n t h after operation of sepsis and liver failure.
Outcome relative to the durability of the stricture repair was assessed by using the grading system previously described (Table V). Treatment failure occurred in two patients, and one patient displayed persistent significantly elevated liver function study results (Table VI). In case 1 the patient had u n d e r g o n e radiation treatment to the right upper quadrant, and the ongoing problems encountered may have reflected hepatic parenchymal damage resulting from radiation therapy, because the anastomosis remained patent until the patient died of liver and kidney failure 11 years later. Case 2 represented a technical failure of the anastomosis, because postoperative dilatation was required 2 years after operation. Iatrogenie biliary strictures. Of the 45 patients with iatrogenic strictures, 26 strictures were incurred at the time of open cholecystectomy, 16 at laparoscopic cholecystectomy, 2 after endoscopic sphincterotomy, and 1 after vagotomy and pyloroplasty. In 34 patients the initial biliaiy repair was performed at our institution, whereas repair followed a previous attempt performed elsewhere in 10 and two previous attempts in 1. The 14 m e n and 31 women had a mean age of 51.6 years (range, 24 to 86 years). Abdominal ultrasonography or abdominal computed tomography was the most c o m m o n initial investigation. ERCP was used alone diagnostically in 12 (27%), percutaneous transhepatic cholangiography alone in 16 (36%), or both in 16 (36%). Investigations performed before referral were used for both diagnosis and planning of operation in one patient. Operation was performed on presentation in those patients without biliary fistula, tight upper quadrant inflammation, or sepsis and was deferred for more optimal local conditions in the right upper quadrant in those patients in whom these complicating features
Surgery Volume 118, Number 4
McDonald et al.
587
T a b l e VI. Benign biliary strictures with unsatisfactory outcome as a result of operative death, cholangitis, or
requiring reoperation or dilation of anastomosis
Age Case (yr) Gender
Cause
Nonsurgically related strictures 1 67 M Radiation therapy
Bismuth class
HeppPrimary (1 ~ or Grade Couinaud secondary (2 ~ Procedure result technique repair
I
HPJ
C
No
Anastomosis patent, persistent elevated liver function test results; died 11 yr after operation Required dilation for recurrent cholangitis 2 yr after operation; died of Hodgkin's disease 3 yr after operation Operative death
2
28
M
Radiation therapy
II
HPJ
D
No
3
44
F
Benign fibrosing sclerosis
IV
HPJ
D
Yes
M
Open cholecystectomy
II
HPJ
C
Yes
1~
Iatrogenic 4 68
Comments
5
67
M
Open cholecystectomy
I
Duct-toduct (e-e)
D
No
1~
6
37
M
Open Cholecystectomy
I
CDJ
D
No
1~
7
70
M
Open cholecystectomy
IV
Mucosal
D
No
1~
g~t 8
30
M
Laparoscopic cholecystectomy
1V
HPJ
D
No
1o
9
41
M
Open cholecystectomy
II
HPJ
D
No
2~
Hepatic lithiasis with multiple intrahepatic biliary strictures Alternative procedure a consideration Portal hypertension prevented elevation hilar plate; multiple intrahepatic strictures Mternative procedure a consideration Right hepatic lobar atrophy; right and left sectoral duct strictures Hilar plate not elevated
HPJ, Hepaticojejunostomy; e-e, end-to-end; CA),],choledochojejunostorny.
were present. The m e d i a n time from injury to repair was 8.2 m o n t h s (range, 10 days to 26 years). The most c o m m o n m e t h o d of reconstruction, the Roux-en-Y hepaticojejunostomy, was used in 38 patients. Alternative procedures were used in the remaining seven patients (Table III). The H e p p - C o u i n a u d
m e t h o d with hilar plate elevation, which enabled performance of a side-to-side left m a i n hepaticojejunostomy (or double hepaficojejunostomy for type IV stricture), was used in 21 cases. The technique used has b e e n described previously.3-5 Transanastomotic stents were used in 33 of the 45 pa-
588
McDonald et al.
Surgery October 1995
80-
O/o 4020"
Hepp-Couinaud method -----
No Yes P=0.032
0
Years from surgery
Fig. 4. Cumulative probability of survival free of reoperation/dilatation for patients with iatrogenic strictures in whom the Hepp-Couinaud method was used (N= 21) compared with those in whom the Hepp-Couinaud method was not used (N= 24). tients and remained a median of 43 days after operation (range, 21 to 461 days). The mean duration of hospitalization was 11.7 days (range, 6 to 36 days). Postoperative major morbidity was observed in 16 patients (36%) (Table IV). No operative deaths occurred in the iatrogenic stricture group. Outcome by Bismuth class and overall was assessed by using the aforementioned grading system (Table V). Mean duration of follow-up was 4.6 years (range, 9.3 months to 11.1 years). The failure rate as a function of time by using the Kaplan-Meier m e t h o d is shown in Fig. 4. For the 21 patients in whom hilar plate elevation was used to facilitate performance of a wide anastomosis of pliable bile duct to intestine, there were 15 patients with a result graded A, five B, and one C. None required postoperative dilation or reoperation (Table V). The effect of a previous attempt at repair was analyzed by comparing time to dilation or reoperation for the patients undergoing primary and secondary reconstruction with the Kaplan-Meier method. No statistically significant difference was noted in failure rates (p = 0.778). A more durable repair was achieved when the HeppCouinaud method was used as compared with those patients in whom standard techniques were used (p = 0.032) (Fig. 4). We were unable to demonstrate that outcome was influenced by age, time delay from injury to reconstruction, preoperative stenting, the n u m b e r of previous repairs, or the duration of postoperative transanastomotic stenting. Of the 45 patients, six had an unsatisfactory outcome (grade C, one patient; grade D, five patients). All patients who required reintervention were male. Critical analysis of those patients in our series with iatrogenic strictures who experienced recurrent cholangitis or required balloon dilation or reoperation warrant c o m m e n t (Table VI). In two patients (cases 5 and
7) alternative procedures may well have been advisable rather than the choledochocholedochostomy and mucosal graft techniques chosen, respectively. For cases 4 and 6 access to the intrahepatic strictures may have been facilitated by placement of a Roux-en-Y access loop in the subcutaneous space, although we have not as yet had the opportunity to use this technique. In case 8 right lobar atrophy and intrahepatic sectoral duct strictures perhaps should have lent consideration to concurrent fight hepatectomy at the time of biliary reconstruction. In case 9 hilar plate elevation was not used and a difficult end-to-side anastomosis was constructed to nonpliable biliary tissue. DISCUSSION
We analyzed our cases of benign stricture repair in two groups because for those patients with strictures associated with chronic pancreatitis, radiation injury, or inflammatory conditions of the biliary tree, ongoing symptoms may represent progression of disease rather than a lack of durability of the reconstruction. This group was included, however, because for patients with iatrogenic strictures, interest has developed recently in nonoperative m a n a g e m e n t of such patients with balloon dilatation or indwelling stents. 6 We thought it would be useful to assess outcome in this somewhat heterogeneous subset to serve as a benchmark for the results of a surgical approach as alternatives are considered in the future. T h e largest subset of patients with nonsurgically related strictures was comprised of those with chronic pancreatitis. The indications for operation in this setring are a matter of debate and not addressed by the present study. Kalvaria et al.7 reported 21 patients undergoing biliary drainage for stenosis resulting from chronic pancreatitis and noted satisfactory results rela-
Surgery Volume 118, Number 4
rive to the biliary tree in 95% of patients with a mean follow-up of 35 months. Stahl et al. 8 noted failure of biliary diversion in three of 18 patients with chronic pancreatitis and bile duct stenosis followed up a mean of 4.4 years; however, failure was observed only in those patients managed initially with T-tube drainage (two patients) or cholecystoenterostomy (one patient). These reports and our data support the efficacy of surgical biliary diversion for those patients with benign biliary duct stricture of nonsurgically related cause and serve as a standard to which alternative therapy, such as balloon dilatation and prolonged stenting, may be compared. On the other hand, both because of the focal characteristics of the inflammatory process and the prevalence of more complex, proximal strictures, failure of operation for iatrogenic stricture if performed before the onset of irreversible liver damage reflects inadequacy of the technical aspects of the reconstruction. Accordingly, this subset of patients serves as the best barometer of the success of biliary reconstruction with a contemporary approach. Many referral centers experienced a bolus effect on referral of bile duct strictures after laparoscopic cholecystectomy as the U.S. surgical community first embraced this new approach to gallbladder removal. 9' 10At our institution between 1990 and 1992, 19 patients were referred for m a n a g e m e n t of iatrogenic laparoscopic bile duct injuriesJ 1 As surgeons have become more facile with laparoscopy and as the technique has become an integral c o m p o n e n t of residency training in general surgery, the rate of iatrogenic bile duct injury appears to be decreasing. Strasberg et al)2 in an extensive review of statewise databases, institutional series, and surveys noted a major bile duct injury rate of 0.52% for laparoscopic cholecystectomy and 0.32% for open cholecystectomy. O n the basis of the increasing n u m b e r of cholecystectomies performed annually since the advent of laparoscopic cholecystectomy and the current rate of major duct injury, they estimated that between 1500 and 2500 bile duct injuries occur within the United States annually. For the 45 patients with iatrogenic injury, excellent or good results based on our grading system were obtained in 87% of cases. The Hepp-Couinaud technique was not used in all patients either because of a low level of injury (e.g., Bismuth I) or by surgeon preference. For the 21 patients in whom the hilar plate was elevated to facilitate performance of a wide mucosa-to-mucosa biliary enteric anastomosis proximal to the area of inflammation and scarring, 95.2% of the patients have experienced excellent or good results (grade A or B). At the time of last follow-up n o n e of the 21 patients had required reintervention. Outcome for these 21 patients in whom hilar plate elevation was used compared favorably with results reported by authors who used the Hepp-Couinaud
McDonald et al.
589
method for proximal bile duct stricture reconstruction. Bismuth 3 reported excellent results in 93% of 120 patients followed up for 10 to 20 years. Only three patients had recurrent stricture requiring reoperation. Myburgh 1"~reported 26 postcholecystectomy strictures, followed up a median of 7 years, with excellent or good results (grade A or B) in 23 (88%); two patients experienced bouts of cholangitis and one patient required operation. Blumgart et al. 5 reported 63 patients undergoing stricture repair with 90% having excellent to good outcome, with a mean follow-up of 3.3 years. Liver function test results were reported as normal in 53 of the surviving 59 patients. The median duration of follow-up for the iatrogenic stricture group in the present study was 4.6 years. Pitt et al) 4 have emphasized the need for prolonged follow-up in assessing outcome. Those authors noted that whereas two thirds of failures had occurred within 3 years and 80% within 5 years, some 20% of therapeutic failures occurred thereafter. Similar observations were reported by Pellegrini et al. 15 These studies underscore the need for routine long-term follow-up for patients undergoing stricture repair, lest occult hepatic damage occur from anastomotic stenosis. Although we are pleased with our results to date, these considerations mandate reassessment of results after a longer period of observation. O u r current practice is to follow up these patients annually with clinical assessment, liver function studies, and ultrasonographic examination. The use of transanastomotic stents for a prolonged period after operation is controversial. In our series outcome was not influenced by the duration of transanastomotic stenting. Clearly, excellent results have been reported without the use of stents by both Bismuth 3 and Myburgh. 1~ O u r own preference is to use stenting for a brief time during perioperative period, both to allow temporary decompression of the biliary system and for postoperative cholangiography, the latter to assess adequacy of the anastomosis. Early imaging may be useful in predicting those patients in whom future problems might develop. Of the 45 cases of iatrogenic stricture repair reported herein, stents were used in 73% for a median of 43 days. The trend presently appears to be away from long-term postoperative stenting. Raute et al. 16 have reported their experience with an access loop comprised of the afferent portion of the Roux-en-Y limb placed subcutaneously or fixed to the undersurface of the anterior abdominal wall as an alternative to longterm stenting for the problematic reconstruction. Previous investigators have noted an increased failure rate for those patients undergoing repair after one or more previous failed attempts. 14 In this study there were 34 primary repairs (no previous attempt) and 11 secondary repairs. O u r results are similar to those reported by Pellegrini et al., ~5 who noted that excellent
590
McDonald et al.
results can still be a c h i e v e d in m o s t patients u n d e r g o i n g s e c o n d a r y o p e r a t i o n . It is possible t h a t with l o n g e r follow-up o f o u r material, a d i f f e r e n c e in o u t c o m e for t h e p r i m a r y a n d s e c o n d a r y r e p a i r g r o u p s w o u l d be appreciated. F u r t h e r m o r e , d u r i n g the p e r i o d o f this investigation alternative therapies w e r e available a n d m a y have b e e n c h o s e n in p r e f e r e n c e to o p e r a t i o n for the m o r e difficult s e c o n d a r y reconstructions, t h e r e b y biasing resuits. Reports o f alternative therapies for i a t r o g e n i c a n d nonsurgically r e l a t e d strictures o f the biliary tree are increasing. In a c o m p a r a t i v e study o f 25 patients m a n a g e d surgically a n d 20 patients m a n a g e d with transhepatic b a l l o o n dilatation, satisfactory results w e r e o b t a i n e d in 88% o f the f o r m e r a n d 55% o f the latter. 17 T h e y cone l u d e d that surgical r e p a i r was m o r e efficacious t h a n b a l l o o n dilatation a n d stenting. T h e e x p e r i e n c e at o u r institution with p e r c u t a n e o u s t e c h n i q u e s was r e p o r t e d by Williams et al., 18 w h e r e i n 74 p o s t o p e r a t i v e b e n i g n biliary strictures were o b s e r v e d for a m e a n o f 28 m o n t h s after b a l l o o n dilatation a n d p r o l o n g e d stenting periods. Strictures r e c u r r e d after stent r e m o v a l in 25%. Serious p r o c e d u r e - r e l a t e d c o m p l i c a t i o n s w e r e o b s e r v e d (sepsis o r b l e e d i n g ) in 28% w h e n strictures w e r e dilated transhepatically. T h e m o r b i d i t y was m i n i m a l w h e n a surgically established t u b e tract was u s e d for access to t h e biliary tree. S o m e a u t h o r s r e p o r t results for e n d o s c o p i c s t e n t i n g comparable to those achieved at their centers for patients m a n a g e d surgically a n d offer the t r e a t m e n t modality as a valid alternative to operative intervention. 6' 19, 2o A l t h o u g h we a g r e e that m i n o r biliary leaks f r o m t h e cystic d u c t stump, g a l l b l a d d e r bed, o r tangential bile d u c t injuries are a m e n a b l e to e n d o s c o p i c o r p e r c u t a n e ous t h e r a p y as definitive t r e a t m e n t , 21 it is the c o n s e n s u s o f the multidisciplinary t e a m o f specialists at o u r institution that all o t h e r patients with b e n i g n bile d u c t strictures c o n s i d e r e d g o o d c a n d i d a t e s for o p e r a t i o n s h o u l d u n d e r g o definitive surgical stricture repair. F o r those patients with p r o x i m a l strictures u n d e r g o i n g o p e r a t i o n , the H e p p - C o u i n a u d m e t h o d s h o u l d b e strongly conside r e d for r e c o n s t r u c t i o n to m a x i m i z e a n a s t o m o t i c durability a n d t h e r e b y o u t c o m e .
REFERENCES 1. Walters W, RamsdellJA. Study of three hundred eight operations for stricture of bile ducts: follow-up periods of one to five or five to twenty-fiveyears. JAMA 1959;171:872-5. 2. HeppJ, Couinaud C. L'abord et l'utilisation du canal hepatique gauche dans les reparations de la voie biliaire principle. Presse Med 1956;64:947-8. 3. Bismuth H. Postoperative strictures of the bile duct. Blumgart LH, ed. Surgery of the liver and biliary tract. Edinburgh: Churchill Livingstone, 1982:209-18. 4. Blumgart LH, Kelley CJ. Hepaticojejunostomy in benign and malignant high bile duct stricture: approaches to the left hepatic ducts. BrJ Surg 1984;71:25%61.
Surgery October 1995 5. Blumgart LH, Kelley CJ, Benjamin IS. Benign bile duct stricture following cholecystectomy: critical factors in management. BrJ Surg 1984;71:836-43. 6. Geenen DJ, GeenenJE, Hogan WJ, et al. Endoscopic therapy for benign bile duct strictures. Gastrointest Endosc 1989;35:367-71. 7. Kalvaria I, Bornman PC, Marks IN, Girdwood AH, Bank L, Kottier RE. The spectrum and natural history of common bile duct stenosis in chronic alcohol-induced pancreatitis. Ann Surg 1989;210:608-13. 8. Stahl TJ, Allen MO, Ansel HJ, Vennes JA. Partial biliary obstruction caused by chronic pancreatitis: an appraisal of indications for surgical biliary drainage. Ann Surg 1988;207:26-32. 9. Branum G, Schmitt C, Baillie J, et al. Management of major biliary complications after laparoscopic cholecystectomy. Ann Surg 1993;217:532-41. 10. Soper NJ, Flye W, Brunt LM, et al. Diagnosis and management of biliary complications of laparoscopic cholecystectomy. Am J Surg 1993;165:663-9. 11. Ress AM, Sarr MG, Nagorney DM, Farnell MB, Donohue JH, McIlrath DC. Spectrum and management of major complications of laparoscopic cholecystectomy. AmJ Surg 1993;165:65562. 12. Strasbevg SM, Herd M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am CoU Surg 1995;180:101-25. 13. Myburgh JA. The Hepp-Couinaud approach to strictures of the bile ducts. Ann Surg 1993;218:615-20. 14. Pitt HA, Miyamoto T, Parapatis SK, Tompkins RK, Longmire WP Jr. Factors influencing outcome in patients with postoperative biliary strictures. AmJ Surg 1982;144:14-21. 15. Pellegrini CA, Thomas MJ, Way LW. Recurrent biliary stricture: patterns of recurrence and outcome of surgical therapy. Am J Surg 1984;147:17580. 16. Raute M, Podlech P,Jaschke W, Manegold BC, Trede M, Chir B. Management of bile duct injuries and strictures following cholecystectomy. World J Surg 1993;17:553-62. 17. Pitt HA, Kaufman SL, Coleman J, White RI, CameronJL. Benign postoperative biliary strictures: Operate or dilate? Ann Surg 1989;210:41%27. 18. Williams HJ, Bender CE, May GR. Benign postoperative biliary strictures: dilation with fluoroscopic guidance. Radiology 1987; 163:629-34. 19. Davids PHP, Ranws EAJ,Coene PPLO, Tytgat GNJ, Huibregtse K. Gastrointest Endosc 1992;38:12-8. 20. Davids PHP, Tanka AKF, Rauws EAJ, et al. Benign biliary strictures: Surgery or endoscopy? Ann Surg 1993;217:237~t3. 21. Woods MS, ShellitoJL, Santoscopy GS, et al. Cystic duct leaks in laparoscopic cholecystectomy. Am J 8urg 1994;168:560-70.
DISCUSSION Dr. Robert E. Hermann (Cleveland, Ohio). Injuries and strictures of the bile duct have been an interest of mine for many years, and our experience with these problems at the Cleveland Clinic is similar to that of the Mayo Clinic. We too have seen an increased number of injuries and strictures during the past 5 years with the advent of laparoscopic cholecystectomy. I want to compliment you on your low mortality rate of 1.4% with these complicated operations and with their overall success rate of almost 88%. In a series of 105 patients that we reported in 1986 our mortality rate was 4% and our success rate was 82%. One of the points we made at that time was that if a stricture repair failed, a second or even a third repair could be performed with expectations of success in from 75% to 80%
Surgery Volume 118, Number 4
of patients, resulting in a cumulative eventual success rate of 93% in our group of patients. I agree with you that an important determinant of success is to get well above the scar tissue at the level of the obstruction to normal soft ductal tissue and to make the anastomosis as wide as possible. The Hepp-Couinaud technique is an excellent method to provide this exposure in u p p e r duct repairs, Bismuth II, III, or IV strictures. A challenge often is to find the bile ducts when scar tissue is dense and distorts the anatomy. We have found that preoperative placement of a transhepatic tube, leaving the catheter in after a percutaneous transhepatic cholangiogram, is often helpful because you can palpate the tube. But this is controversial because it also decompresses the distended bile ducts to some extent. Would you describe for us your technique for locating the bile duct in difficult recurrent strictures, the ones that we have had the most challenge with? Also why do you believe your success rate was not changed or influenced by the level of the stricture or by the n u m b e r of previous repairs, both of which influenced in a negative way the experience reported from our institution and from most other centers? Dr. Thomas A. Stellato (Cleveland, Ohio). Because the duration of transanastomotic stenting did not seem to influence the outcome, could you c o m m e n t as to which patients you would stent and how long you would leave the stents in place? Dr. Gerald M. I.arson (Louisville, Ky.). Two years ago Dr. Vitale and our group presented to this association our initial experience with ERCP and stenting for strictures that were short and in the distal bile duct. We have expanded our experience and our indications with this now, and using a stenting program that lasts up to 1 year for benign strictures, we have had quite good results. Clearly, in some patients on whom one does not want to operate and in whom the c o m m o n duct is not completely divided the endoscopic approach seems to be attractive. Would you c o m m e n t on the endoscopic approach from your experience? Dr. Farnell (closing). Dr. H e r m a n n asked about our results with primary versus secondary repair. There are basically two reasons why the results observed were no different for the primary and secondary repairs. The Hepp-Couinaud technique is the first reason, in many of the secondary repairs we were able to get proximal to the site of stricture and inflammation and obtain pliable, well vascularized bile duct, which allowed performance of a technically satisfactory anastomosis. The second reason is likely related, at least partially, to selection bias. This is a contemporary series during which alternatives for the management of patients with very complicated proximal strictures were available. Although specific data are not available, it may well be that some of the patients who were not considered good candidates for anatomic reconstruction underwent either endoscopic or percutaneous dilatation, thus biasing favorably our results for secondary reconstructions. Dr. Herman also asked about the use of preoperative stents
McDonald et al.
591
in terms of using the stent to help one localize the bile duct. It is not particularly difficult to find the bile duct if one uses the Hepp-Couinaud technique. The quadrate lobe, segment IV, protects that area from inflammation and scarring and is a very constant anatomic feature. If one uses hilar plate elevation, one can generally find one's way to the bile duct. Having said that, my preference is to have a transhepatic tube placed before operation to avoid the n e e d to place the transhepatic tube during operation. I have not been impressed that the bile duct shrinks that much if preoperative decompression is performed. If a transhepatic tube is not placed before operation, my own preference is to pass a threaded Bakes dilator (Codman, Randolph, Mass.) transhepatically and attach a threaded guide wire. The Seldinger technique is then used to advance a locking catheter transhepatically over the guide wire to gain access to the biliary tree. Dr. Stellato asked about given that the duration of stenting d i d n ' t seem to make any difference, if one leaves stents, then for how long? My personal preference is to leave stents in for about 3 weeks: This time period allows decompression of the anastomosis during perioperative period and performance of postoperative cholangiography. The latter helps one to prognosticate regarding the technical quality of anastomosis. Also, if one is not particularly happy with it for some reason, one still has access to the biliary tree so that intervention can be undertaken, l f o n e is pleased with the anatomic features on cholangiography, then our preference is to remove the tube at 21 days. Dr. Larson asked about endoscopic approaches to partial injuries of the bile duct. Certainly this is gaining increased interest across the country and around the world. I do not have any data on our experience with endoscopic balloon dilatation and stenting. I can c o m m e n t regarding transhepatic stenting. Hugh Williams and colleagues18 of our interventional radiology group reported 74 patients who had partial strictures of the ductal system during a 5-year time period. With a mean follow-up of 28 months, the transhepatic balloon dilatation and stenting failed in 25% of the patients. The mean duration of stenting was about 8 months for those patients. They noted that the rates of infection and bleeding were higher in those patients in whom access to the biliary tree had to be gained by puncturing the liver, whereas those complications were not seen in patients in whom the surgeon had left a transanastomotic stent or a T-tube in place. The point was made that if one anticipates difficulty with one's anastomosis, one should consider providing external access to the biliary tree to facilitate postoperative interventional radiolog~c procedures. Alternatively, there has been interest in placing the afferent portion of the Roux-en-u limb subcutaneously in patients to facilitate access to the biliary tree. This is a very interesting concept, although I cannot c o m m e n t from experience. We have not had an opportunity to utilize the technique as yet.
Background. The Hepp-Couinaud technique is an innovative approach for repair of proximal biliary strictures. We have used this method selectivelyfor bile duct reconstruction since 1982. Our aim was to analyze our experience with the surgical repah" of benign biliary strictures in the decade since the Hepp-Couinaud technique has become an integral component of our surgical management strategy. Methods. Seventy-two patients undergoing surgical repair of benign biliary stricture between 1983 and 1992 were reviewed retrospectively. A grading system on clinical symptoms, results of liver function studies, and need for reintervention was used to assess outcome. Results. For the 27 patients with noniatrogenic strictures, followed up a mean of 3. 9 years, excellent or good results (grade A or B) were obtained in 88.9%. For the 45 patients with iatrogenic strictures, followed up a mean of 4. 6 years, 86. 7 % were categorized as grade A or B. The cumulative probability of anastomotic failure was significantly lessfor the 21 patients in whom the Hepp-Couinaud method was used when compared with the 24 patients in whom it was not (p = O.032). Outcome was not influenced by age, time delay from injury to reconstruction, preoperative stenting, the number of previous repairs, or the duration of postoperative stenting. Conclusions. Surgical reconstruction affords excellent or good results for the vast majority of patients with benign biliary strictures. For proximal iatrogenic strictures superior anastomotic durability is achieved with the Hepp-Couinaud technique. (SURGERY1995;118:582-91.) From the Department of Surgery and Department of Health SciencesResearch, Mayo Clinic, Rochester, Minn.
ALTHOUGH BENIGN BILIARYSTRICTURES are caused by iatrogenic injury in most patients, inflammatory processes of the bile duct or adjacent organs may also result in ductal stricture. The technique of bile duct repair has become standard and consists of either duct-to-duct or biliary enteric anastomoses. In the last large series from our institution 1 the outcome of stricture repair in 265 patients with a m i n i m u m of 5 years of follow-up was satisfactory in only 61%. Interest in surgical repair of benign bile duct strictures has been rekindled by several developments. First, the advent of laparoscopic cholecystectomy has led to increased referral of patients requiting biliary reconstruction. Second, both endoscopic and percutaneous balloon dilatation and stenting have been advanced as alternatives to operation for both iatrogenic and inflammatory bile duct strictures. Third, an innovative surgical approach to proximal strictures of the extrahepatic biliary tree, the Hepp-Couinaud approach, 2 has facilitated the performance of a wide, muPresented at the Fifty-secondAnnual Meeting of the Central Surgical Association, Cleveland, Ohio, March 9-11, 1995. Reprint requests: Michael Farnell, MD, MayoClinic, 200 First St. SW, Rochester, MN 55905. Copyright 9 1995 by Mosby-YearBook, Inc. 0039-6060/95/$5.00 + 0 11/6/66623 582
SURGERY
cosa-to-mucosa anastomosis of pliable, well vascularized bile duct to gut. First described in 1956 in the French literature, the Hepp-Couinaud approach was popularized in Europe by Bismuth 3 and Blumgart et al4, 5 but has not been used widely in the United States. We became aware of this technique and began using the approach in our practice in 1982. Since that time we have increasingly used this approach, where applicable, for the management of proximal biliary strictures. O u r aim was to review our contemporary experience with the surgical repair of benign biliary strictures with specific reference to the Hepp-Couinaud method.
PATIENTS AND METHODS The records of patients undergoing operation for benign biliary stricture between 1983 and 1992 were reviewed. Malignant strictures or benign strictures associated with either sclerosing cholangitis or liver transplantation were excluded. The medical records w e r e reviewed with reference to cause, details of surgical management, hospital course, and outcome. Follow-up was obtained by review of records of subsequent visits and supplemented by p h o n e interviews with the patient and primary physician. The strictures were classified on the basis of radiologic and operative findings after the m e t h o d of Bismuth. 3
Surgery Volume 118, Number 4
McDonald et aL
Segment
i//.//,.
583
!1,2 3
cy, ic plate
Urob, ca, / ~ / ~:~o
A
u.,_. Hilar plate
plate
B Fig. 1. A, Left main hepatic duct, left main portal vein, and left hepatic artery are invested within a vasculobiliary sheath, the hilar plate, which consists of condensation of endoabdominal fascia. Note transverse orientation of left main hepatic duct at base of segment IV. Access to left main hepatic duct is gained by incising Glisson's capsule at base of segment IV and retracting segment IV cephalad. Vasculobiliary sheath is incised exposing origin of fight main hepatic duct, the confluens, and left main hepatic duct, B, Sagittal section of liver through segment IV, which shows extrahepatic and yet protected location of left main hepatic duct, anterior and superior to left main portal vein and left hepatic artery. Arrow indicates plane of dissection at base of segment IV to facilitate access to left main hepatic duct.
The Hepp-Couinaud technique was used for proximal iatrogenic biliary strictures on the basis of surgeon preference. The Hepp-Couinaud technique capitalizes on the rather long extrahepafic course of the left main hepatic duct nestled beneath the quadrate lobe (segm e n t IV). Although the left main hepatic duct is extrahepatic and can be accessed without the need for dissection of hepatic parenchyma, protection is afforded both by location beneath the base of the quadrate lobe and investment within a condensation of the endoabdominal fascia, the hilar plate (Fig. 1). Accord-
ingly, the left main hepatic duct is generally both uninvolved in most bile duct injuries that occur as a result of open or laparoscopic cholecystectomy and also unaffected by inflammation and infection attendant with bile leakage. Access to the left main hepatic duct is obtained by incising the peritoneum at the base of segment IV and retracting segment IV cephalad. Downward traction is applied to the hepatoduodenal ligament, and the hilar plate is incised over the anterior superiorly located left main hepatic duct, which courses transversely beneath the base of segment IV. A 2 to 3 cm
584
McDonald et al.
Surgery October 1995
/
-\
P F ~ MAYO
Fig. 2. Origin of right main hepatic duct, confluens, and left main hepatic duct have been exposed by incising Glisson's capsule at base of segment IV, retracting segment 1V cephalad and then incising vasculobiliary sheath overlying the proximal extrahepatic biliary system. Roux-en-Y loop has been carried through right transverse mesocolon in preparation for 2 to 3 cm side-to-side biliary enteric anastomosis. T a b l e I. Grading system used to evaluate outcome of patients undergoing operation for benign biliary stricture Grade A Grade B Grade C Grade D
Normal liver function test (LFT) results, asymptomatic Mild elevation LFT results, asymptomatic Abnormal LFT results, cholangitis, pain Surgical revision or dilation required
longitudinal incision is made in the left main hepatic duct, which facilitates a very wide-mouth, side-to-side, bile duct-to-jejunal anastomosis (Fig. 2). For those patients in whom the Hepp-Couinaud method was used,
the anastomosis was performed with a single layer of interrupted 4-0 absorbable suture. In most cases the anastomosis was splinted with a transhepatic, transanastomotic catheter (Fig. 3). Follow-up was obtained in all patients. To assess the durability of the repair, a grading system was devised on the basis of the patient's clinical symptoms, laboratory parameters, and the need for further intervention (Table I). Outcome was based on grade at the time of last follow-up. Those patients undergoing dilation or reoperation were censored from the analysis at the time of intervention. Statistical methods. Survivorship free of failure (the need for reoperation or dilatation) was estimated as a function of time from operation by using the KaplanMeier method. Ninety-five percent confidence intervals are presented on all survival curves. Comparisons of
Surgery Volume 118, Number 4
McDonald et al.
585
MAYO 9
Fig. 3. Side-to-side, left main hepaticojejunostomy. Transhepatic, transanastomotic locking catheter is placed before initiation of suture placement and used both to decompress biliary system during perioperative period and to allow postoperative radiographic imaging. Anterior layer of sutures is placed initially and secured sequentially in a spring keeper. Posterior layer is completed. Transanastomotic splint is then directed into limb of jejunum with side holes laying both above and below anastomosis. Lastly, anterior row of sutures is placed in the jejunum and tied (after method of Blumgart and Kelley).
individual survivorship curves, for example, between iatrogenic and noniatrogenic patients, were made with log-rank tests. The relationships between continuous variables such as age and time from injury to repair were investigated with the Cox proportional hazards model. Chi-squared tests were used to c o m p a r e proportions, and Wilcoxon rank-sum tests were used to compare ordinal results such as outcome. All significance tests were two-sided, and p values less than 0.05 were considered statistically significant.
T a b l e II. Bismuth classification of benign biliary strictures (N= 72)
I II III IV V
Iatrogenic (N = 45)
Noniatrogenic (N = 27)
13 18 7 5 2
22 3 1 1 --
RESULTS Between 1983 and 1992, 72 patients underwent opera t i o n for biliary stricture resulting from either iatrogenic or nonsurgically related causes. The 45 iatrogenic and 27 noniatrogenic strictures were classified by the Bismuth system (Table II). NonsurgicaUy related strictures. The majority of the 27 patients with nonsurgically related strictures were classified as Bismuth type I (Table II). The 18 m e n and 9 women had a mean age of 49.9 years (range, 22 to 84 years). The cause of the stricture was chronic pancreatitis in 14 (52%), unknown cause in 10 (37%), radiation in 2 (7%), and external blunt trauma in 1 (4%). Mean
duration of hospitalization was 12.5 days (range, 5 to 55 days). Mean duration of follow-up was 3.9 years (range, 3.2 to 11 years). Abdominal ultrasonography or abdominal c o m p u t e d tomography was used before operation most commonly. Endoscopic retrograde cholangiopancreatography (ERCP) was used diagnostically in 16 patients, percutaneous transhepatic cholangiography alone in two, and both in five, Neither investigation was obtained in four patients. The procedures used for managing the strictures are shown in Table III and reflect the fact that the majority were Bismuth type I; in some cases either concern regarding malignancy or in-
586
McDonald et al.
Surgery October 1995
Table III. Operative procedures used for benign biliary strictures (N= 72) Iat,vgenic Couinaud)* Noniatrogenic
Roux-en-Y hepaticojejunostomy Roux-en-Y choledochoj ej unostomy Hepaticoduodenostomy Choledochoduodenostomy Duct-to-duct anastomosis Whipple Cholecystoj ejunostomy, pancreaticoj ejunostomy Transduodenal sphincteroplasty Stricturoplasty TOTAL
Grade result Bismuth type
(HeppProcedure
Table V. Result as function of Bismuth classification
38 (19)
4
2 (1)
3
2 (1) 1 1 0 0
0 10 0 6 2
1 0 45 (21)
1 1 27
A
B
Iatrogenic strictures (N= 45) I 10 (2) 1 (0) II 12 (7) 4 (1) III 5 (5) 2 (1) IV 2 (2) 1 (1) V 2(1) 0(0) Overall 31 (17) 8 (3) Nonsurgically related strictures I 15 6 II 2 0 III 0 1 1V 0 0 Overall 17 7
C
D
0 (0) 2 (0) 1 (1) 1 (0) 0 (0) 0 (0) 0 (0) 2 (0) 0 ( 0 ) 0(0) 1 (1) 5 (0) (N= 27) 1 0 0 1 0 0 0 1 1 2
% A +B
84.6 88.9 100,0 60.0 100,0 87.7 (95.2) 95.5 66.7 100.0 0 88.9
Numbers in parentheses represent those patients with iatrogenic smctures in whom the Hepp-Couinaud technique was used.
*Numbers in parentheses denote those patients with iatrogenic stricture in whom Hepp-Couinaud method was used.
Table IV. Postoperative major complications in patients undergoing operation for benign biliary stricture latrogenic
Deep wound infection Superficial wound infection Intraabdominal abscess Bile peritonitis Intraperitoneal bleeding Acute pancreatitis Retained stone, intrahepatic duct Persistent pyrexia Anastomotic leak Septicemia ReoPeration for retained drain Pulmonary embolism Patients with major complications*
Noniatrogenic
1 2 5 1 1 1 1
1 2 1 0 2 1 0
2 1 1 2
2 l 0 0
0 16 (36%)
1 7 (26%)
*Some patients experienced more than one major complication.
tractable pain p r o m p t e d resection of the stricture. Transanastomotic stents were used in 10 patients for a mean of 24 days after operation (range, 14 to 153 days). Major morbidity occurred in seven patients (26%) (Table IV). Operative death occurred in one patient with a Bismuth type IVstricture. That patient underwent resection of the stricture with a double hepaticojejunostomy, experienced intraperitoneal hemorrhage after operation requiring reoperafion, and died approximately 1 m o n t h after operation of sepsis and liver failure.
Outcome relative to the durability of the stricture repair was assessed by using the grading system previously described (Table V). Treatment failure occurred in two patients, and one patient displayed persistent significantly elevated liver function study results (Table VI). In case 1 the patient had u n d e r g o n e radiation treatment to the right upper quadrant, and the ongoing problems encountered may have reflected hepatic parenchymal damage resulting from radiation therapy, because the anastomosis remained patent until the patient died of liver and kidney failure 11 years later. Case 2 represented a technical failure of the anastomosis, because postoperative dilatation was required 2 years after operation. Iatrogenie biliary strictures. Of the 45 patients with iatrogenic strictures, 26 strictures were incurred at the time of open cholecystectomy, 16 at laparoscopic cholecystectomy, 2 after endoscopic sphincterotomy, and 1 after vagotomy and pyloroplasty. In 34 patients the initial biliaiy repair was performed at our institution, whereas repair followed a previous attempt performed elsewhere in 10 and two previous attempts in 1. The 14 m e n and 31 women had a mean age of 51.6 years (range, 24 to 86 years). Abdominal ultrasonography or abdominal computed tomography was the most c o m m o n initial investigation. ERCP was used alone diagnostically in 12 (27%), percutaneous transhepatic cholangiography alone in 16 (36%), or both in 16 (36%). Investigations performed before referral were used for both diagnosis and planning of operation in one patient. Operation was performed on presentation in those patients without biliary fistula, tight upper quadrant inflammation, or sepsis and was deferred for more optimal local conditions in the right upper quadrant in those patients in whom these complicating features
Surgery Volume 118, Number 4
McDonald et al.
587
T a b l e VI. Benign biliary strictures with unsatisfactory outcome as a result of operative death, cholangitis, or
requiring reoperation or dilation of anastomosis
Age Case (yr) Gender
Cause
Nonsurgically related strictures 1 67 M Radiation therapy
Bismuth class
HeppPrimary (1 ~ or Grade Couinaud secondary (2 ~ Procedure result technique repair
I
HPJ
C
No
Anastomosis patent, persistent elevated liver function test results; died 11 yr after operation Required dilation for recurrent cholangitis 2 yr after operation; died of Hodgkin's disease 3 yr after operation Operative death
2
28
M
Radiation therapy
II
HPJ
D
No
3
44
F
Benign fibrosing sclerosis
IV
HPJ
D
Yes
M
Open cholecystectomy
II
HPJ
C
Yes
1~
Iatrogenic 4 68
Comments
5
67
M
Open cholecystectomy
I
Duct-toduct (e-e)
D
No
1~
6
37
M
Open Cholecystectomy
I
CDJ
D
No
1~
7
70
M
Open cholecystectomy
IV
Mucosal
D
No
1~
g~t 8
30
M
Laparoscopic cholecystectomy
1V
HPJ
D
No
1o
9
41
M
Open cholecystectomy
II
HPJ
D
No
2~
Hepatic lithiasis with multiple intrahepatic biliary strictures Alternative procedure a consideration Portal hypertension prevented elevation hilar plate; multiple intrahepatic strictures Mternative procedure a consideration Right hepatic lobar atrophy; right and left sectoral duct strictures Hilar plate not elevated
HPJ, Hepaticojejunostomy; e-e, end-to-end; CA),],choledochojejunostorny.
were present. The m e d i a n time from injury to repair was 8.2 m o n t h s (range, 10 days to 26 years). The most c o m m o n m e t h o d of reconstruction, the Roux-en-Y hepaticojejunostomy, was used in 38 patients. Alternative procedures were used in the remaining seven patients (Table III). The H e p p - C o u i n a u d
m e t h o d with hilar plate elevation, which enabled performance of a side-to-side left m a i n hepaticojejunostomy (or double hepaficojejunostomy for type IV stricture), was used in 21 cases. The technique used has b e e n described previously.3-5 Transanastomotic stents were used in 33 of the 45 pa-
588
McDonald et al.
Surgery October 1995
80-
O/o 4020"
Hepp-Couinaud method -----
No Yes P=0.032
0
Years from surgery
Fig. 4. Cumulative probability of survival free of reoperation/dilatation for patients with iatrogenic strictures in whom the Hepp-Couinaud method was used (N= 21) compared with those in whom the Hepp-Couinaud method was not used (N= 24). tients and remained a median of 43 days after operation (range, 21 to 461 days). The mean duration of hospitalization was 11.7 days (range, 6 to 36 days). Postoperative major morbidity was observed in 16 patients (36%) (Table IV). No operative deaths occurred in the iatrogenic stricture group. Outcome by Bismuth class and overall was assessed by using the aforementioned grading system (Table V). Mean duration of follow-up was 4.6 years (range, 9.3 months to 11.1 years). The failure rate as a function of time by using the Kaplan-Meier m e t h o d is shown in Fig. 4. For the 21 patients in whom hilar plate elevation was used to facilitate performance of a wide anastomosis of pliable bile duct to intestine, there were 15 patients with a result graded A, five B, and one C. None required postoperative dilation or reoperation (Table V). The effect of a previous attempt at repair was analyzed by comparing time to dilation or reoperation for the patients undergoing primary and secondary reconstruction with the Kaplan-Meier method. No statistically significant difference was noted in failure rates (p = 0.778). A more durable repair was achieved when the HeppCouinaud method was used as compared with those patients in whom standard techniques were used (p = 0.032) (Fig. 4). We were unable to demonstrate that outcome was influenced by age, time delay from injury to reconstruction, preoperative stenting, the n u m b e r of previous repairs, or the duration of postoperative transanastomotic stenting. Of the 45 patients, six had an unsatisfactory outcome (grade C, one patient; grade D, five patients). All patients who required reintervention were male. Critical analysis of those patients in our series with iatrogenic strictures who experienced recurrent cholangitis or required balloon dilation or reoperation warrant c o m m e n t (Table VI). In two patients (cases 5 and
7) alternative procedures may well have been advisable rather than the choledochocholedochostomy and mucosal graft techniques chosen, respectively. For cases 4 and 6 access to the intrahepatic strictures may have been facilitated by placement of a Roux-en-Y access loop in the subcutaneous space, although we have not as yet had the opportunity to use this technique. In case 8 right lobar atrophy and intrahepatic sectoral duct strictures perhaps should have lent consideration to concurrent fight hepatectomy at the time of biliary reconstruction. In case 9 hilar plate elevation was not used and a difficult end-to-side anastomosis was constructed to nonpliable biliary tissue. DISCUSSION
We analyzed our cases of benign stricture repair in two groups because for those patients with strictures associated with chronic pancreatitis, radiation injury, or inflammatory conditions of the biliary tree, ongoing symptoms may represent progression of disease rather than a lack of durability of the reconstruction. This group was included, however, because for patients with iatrogenic strictures, interest has developed recently in nonoperative m a n a g e m e n t of such patients with balloon dilatation or indwelling stents. 6 We thought it would be useful to assess outcome in this somewhat heterogeneous subset to serve as a benchmark for the results of a surgical approach as alternatives are considered in the future. T h e largest subset of patients with nonsurgically related strictures was comprised of those with chronic pancreatitis. The indications for operation in this setring are a matter of debate and not addressed by the present study. Kalvaria et al.7 reported 21 patients undergoing biliary drainage for stenosis resulting from chronic pancreatitis and noted satisfactory results rela-
Surgery Volume 118, Number 4
rive to the biliary tree in 95% of patients with a mean follow-up of 35 months. Stahl et al. 8 noted failure of biliary diversion in three of 18 patients with chronic pancreatitis and bile duct stenosis followed up a mean of 4.4 years; however, failure was observed only in those patients managed initially with T-tube drainage (two patients) or cholecystoenterostomy (one patient). These reports and our data support the efficacy of surgical biliary diversion for those patients with benign biliary duct stricture of nonsurgically related cause and serve as a standard to which alternative therapy, such as balloon dilatation and prolonged stenting, may be compared. On the other hand, both because of the focal characteristics of the inflammatory process and the prevalence of more complex, proximal strictures, failure of operation for iatrogenic stricture if performed before the onset of irreversible liver damage reflects inadequacy of the technical aspects of the reconstruction. Accordingly, this subset of patients serves as the best barometer of the success of biliary reconstruction with a contemporary approach. Many referral centers experienced a bolus effect on referral of bile duct strictures after laparoscopic cholecystectomy as the U.S. surgical community first embraced this new approach to gallbladder removal. 9' 10At our institution between 1990 and 1992, 19 patients were referred for m a n a g e m e n t of iatrogenic laparoscopic bile duct injuriesJ 1 As surgeons have become more facile with laparoscopy and as the technique has become an integral c o m p o n e n t of residency training in general surgery, the rate of iatrogenic bile duct injury appears to be decreasing. Strasberg et al)2 in an extensive review of statewise databases, institutional series, and surveys noted a major bile duct injury rate of 0.52% for laparoscopic cholecystectomy and 0.32% for open cholecystectomy. O n the basis of the increasing n u m b e r of cholecystectomies performed annually since the advent of laparoscopic cholecystectomy and the current rate of major duct injury, they estimated that between 1500 and 2500 bile duct injuries occur within the United States annually. For the 45 patients with iatrogenic injury, excellent or good results based on our grading system were obtained in 87% of cases. The Hepp-Couinaud technique was not used in all patients either because of a low level of injury (e.g., Bismuth I) or by surgeon preference. For the 21 patients in whom the hilar plate was elevated to facilitate performance of a wide mucosa-to-mucosa biliary enteric anastomosis proximal to the area of inflammation and scarring, 95.2% of the patients have experienced excellent or good results (grade A or B). At the time of last follow-up n o n e of the 21 patients had required reintervention. Outcome for these 21 patients in whom hilar plate elevation was used compared favorably with results reported by authors who used the Hepp-Couinaud
McDonald et al.
589
method for proximal bile duct stricture reconstruction. Bismuth 3 reported excellent results in 93% of 120 patients followed up for 10 to 20 years. Only three patients had recurrent stricture requiring reoperation. Myburgh 1"~reported 26 postcholecystectomy strictures, followed up a median of 7 years, with excellent or good results (grade A or B) in 23 (88%); two patients experienced bouts of cholangitis and one patient required operation. Blumgart et al. 5 reported 63 patients undergoing stricture repair with 90% having excellent to good outcome, with a mean follow-up of 3.3 years. Liver function test results were reported as normal in 53 of the surviving 59 patients. The median duration of follow-up for the iatrogenic stricture group in the present study was 4.6 years. Pitt et al) 4 have emphasized the need for prolonged follow-up in assessing outcome. Those authors noted that whereas two thirds of failures had occurred within 3 years and 80% within 5 years, some 20% of therapeutic failures occurred thereafter. Similar observations were reported by Pellegrini et al. 15 These studies underscore the need for routine long-term follow-up for patients undergoing stricture repair, lest occult hepatic damage occur from anastomotic stenosis. Although we are pleased with our results to date, these considerations mandate reassessment of results after a longer period of observation. O u r current practice is to follow up these patients annually with clinical assessment, liver function studies, and ultrasonographic examination. The use of transanastomotic stents for a prolonged period after operation is controversial. In our series outcome was not influenced by the duration of transanastomotic stenting. Clearly, excellent results have been reported without the use of stents by both Bismuth 3 and Myburgh. 1~ O u r own preference is to use stenting for a brief time during perioperative period, both to allow temporary decompression of the biliary system and for postoperative cholangiography, the latter to assess adequacy of the anastomosis. Early imaging may be useful in predicting those patients in whom future problems might develop. Of the 45 cases of iatrogenic stricture repair reported herein, stents were used in 73% for a median of 43 days. The trend presently appears to be away from long-term postoperative stenting. Raute et al. 16 have reported their experience with an access loop comprised of the afferent portion of the Roux-en-Y limb placed subcutaneously or fixed to the undersurface of the anterior abdominal wall as an alternative to longterm stenting for the problematic reconstruction. Previous investigators have noted an increased failure rate for those patients undergoing repair after one or more previous failed attempts. 14 In this study there were 34 primary repairs (no previous attempt) and 11 secondary repairs. O u r results are similar to those reported by Pellegrini et al., ~5 who noted that excellent
590
McDonald et al.
results can still be a c h i e v e d in m o s t patients u n d e r g o i n g s e c o n d a r y o p e r a t i o n . It is possible t h a t with l o n g e r follow-up o f o u r material, a d i f f e r e n c e in o u t c o m e for t h e p r i m a r y a n d s e c o n d a r y r e p a i r g r o u p s w o u l d be appreciated. F u r t h e r m o r e , d u r i n g the p e r i o d o f this investigation alternative therapies w e r e available a n d m a y have b e e n c h o s e n in p r e f e r e n c e to o p e r a t i o n for the m o r e difficult s e c o n d a r y reconstructions, t h e r e b y biasing resuits. Reports o f alternative therapies for i a t r o g e n i c a n d nonsurgically r e l a t e d strictures o f the biliary tree are increasing. In a c o m p a r a t i v e study o f 25 patients m a n a g e d surgically a n d 20 patients m a n a g e d with transhepatic b a l l o o n dilatation, satisfactory results w e r e o b t a i n e d in 88% o f the f o r m e r a n d 55% o f the latter. 17 T h e y cone l u d e d that surgical r e p a i r was m o r e efficacious t h a n b a l l o o n dilatation a n d stenting. T h e e x p e r i e n c e at o u r institution with p e r c u t a n e o u s t e c h n i q u e s was r e p o r t e d by Williams et al., 18 w h e r e i n 74 p o s t o p e r a t i v e b e n i g n biliary strictures were o b s e r v e d for a m e a n o f 28 m o n t h s after b a l l o o n dilatation a n d p r o l o n g e d stenting periods. Strictures r e c u r r e d after stent r e m o v a l in 25%. Serious p r o c e d u r e - r e l a t e d c o m p l i c a t i o n s w e r e o b s e r v e d (sepsis o r b l e e d i n g ) in 28% w h e n strictures w e r e dilated transhepatically. T h e m o r b i d i t y was m i n i m a l w h e n a surgically established t u b e tract was u s e d for access to t h e biliary tree. S o m e a u t h o r s r e p o r t results for e n d o s c o p i c s t e n t i n g comparable to those achieved at their centers for patients m a n a g e d surgically a n d offer the t r e a t m e n t modality as a valid alternative to operative intervention. 6' 19, 2o A l t h o u g h we a g r e e that m i n o r biliary leaks f r o m t h e cystic d u c t stump, g a l l b l a d d e r bed, o r tangential bile d u c t injuries are a m e n a b l e to e n d o s c o p i c o r p e r c u t a n e ous t h e r a p y as definitive t r e a t m e n t , 21 it is the c o n s e n s u s o f the multidisciplinary t e a m o f specialists at o u r institution that all o t h e r patients with b e n i g n bile d u c t strictures c o n s i d e r e d g o o d c a n d i d a t e s for o p e r a t i o n s h o u l d u n d e r g o definitive surgical stricture repair. F o r those patients with p r o x i m a l strictures u n d e r g o i n g o p e r a t i o n , the H e p p - C o u i n a u d m e t h o d s h o u l d b e strongly conside r e d for r e c o n s t r u c t i o n to m a x i m i z e a n a s t o m o t i c durability a n d t h e r e b y o u t c o m e .
REFERENCES 1. Walters W, RamsdellJA. Study of three hundred eight operations for stricture of bile ducts: follow-up periods of one to five or five to twenty-fiveyears. JAMA 1959;171:872-5. 2. HeppJ, Couinaud C. L'abord et l'utilisation du canal hepatique gauche dans les reparations de la voie biliaire principle. Presse Med 1956;64:947-8. 3. Bismuth H. Postoperative strictures of the bile duct. Blumgart LH, ed. Surgery of the liver and biliary tract. Edinburgh: Churchill Livingstone, 1982:209-18. 4. Blumgart LH, Kelley CJ. Hepaticojejunostomy in benign and malignant high bile duct stricture: approaches to the left hepatic ducts. BrJ Surg 1984;71:25%61.
Surgery October 1995 5. Blumgart LH, Kelley CJ, Benjamin IS. Benign bile duct stricture following cholecystectomy: critical factors in management. BrJ Surg 1984;71:836-43. 6. Geenen DJ, GeenenJE, Hogan WJ, et al. Endoscopic therapy for benign bile duct strictures. Gastrointest Endosc 1989;35:367-71. 7. Kalvaria I, Bornman PC, Marks IN, Girdwood AH, Bank L, Kottier RE. The spectrum and natural history of common bile duct stenosis in chronic alcohol-induced pancreatitis. Ann Surg 1989;210:608-13. 8. Stahl TJ, Allen MO, Ansel HJ, Vennes JA. Partial biliary obstruction caused by chronic pancreatitis: an appraisal of indications for surgical biliary drainage. Ann Surg 1988;207:26-32. 9. Branum G, Schmitt C, Baillie J, et al. Management of major biliary complications after laparoscopic cholecystectomy. Ann Surg 1993;217:532-41. 10. Soper NJ, Flye W, Brunt LM, et al. Diagnosis and management of biliary complications of laparoscopic cholecystectomy. Am J Surg 1993;165:663-9. 11. Ress AM, Sarr MG, Nagorney DM, Farnell MB, Donohue JH, McIlrath DC. Spectrum and management of major complications of laparoscopic cholecystectomy. AmJ Surg 1993;165:65562. 12. Strasbevg SM, Herd M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am CoU Surg 1995;180:101-25. 13. Myburgh JA. The Hepp-Couinaud approach to strictures of the bile ducts. Ann Surg 1993;218:615-20. 14. Pitt HA, Miyamoto T, Parapatis SK, Tompkins RK, Longmire WP Jr. Factors influencing outcome in patients with postoperative biliary strictures. AmJ Surg 1982;144:14-21. 15. Pellegrini CA, Thomas MJ, Way LW. Recurrent biliary stricture: patterns of recurrence and outcome of surgical therapy. Am J Surg 1984;147:17580. 16. Raute M, Podlech P,Jaschke W, Manegold BC, Trede M, Chir B. Management of bile duct injuries and strictures following cholecystectomy. World J Surg 1993;17:553-62. 17. Pitt HA, Kaufman SL, Coleman J, White RI, CameronJL. Benign postoperative biliary strictures: Operate or dilate? Ann Surg 1989;210:41%27. 18. Williams HJ, Bender CE, May GR. Benign postoperative biliary strictures: dilation with fluoroscopic guidance. Radiology 1987; 163:629-34. 19. Davids PHP, Ranws EAJ,Coene PPLO, Tytgat GNJ, Huibregtse K. Gastrointest Endosc 1992;38:12-8. 20. Davids PHP, Tanka AKF, Rauws EAJ, et al. Benign biliary strictures: Surgery or endoscopy? Ann Surg 1993;217:237~t3. 21. Woods MS, ShellitoJL, Santoscopy GS, et al. Cystic duct leaks in laparoscopic cholecystectomy. Am J 8urg 1994;168:560-70.
DISCUSSION Dr. Robert E. Hermann (Cleveland, Ohio). Injuries and strictures of the bile duct have been an interest of mine for many years, and our experience with these problems at the Cleveland Clinic is similar to that of the Mayo Clinic. We too have seen an increased number of injuries and strictures during the past 5 years with the advent of laparoscopic cholecystectomy. I want to compliment you on your low mortality rate of 1.4% with these complicated operations and with their overall success rate of almost 88%. In a series of 105 patients that we reported in 1986 our mortality rate was 4% and our success rate was 82%. One of the points we made at that time was that if a stricture repair failed, a second or even a third repair could be performed with expectations of success in from 75% to 80%
Surgery Volume 118, Number 4
of patients, resulting in a cumulative eventual success rate of 93% in our group of patients. I agree with you that an important determinant of success is to get well above the scar tissue at the level of the obstruction to normal soft ductal tissue and to make the anastomosis as wide as possible. The Hepp-Couinaud technique is an excellent method to provide this exposure in u p p e r duct repairs, Bismuth II, III, or IV strictures. A challenge often is to find the bile ducts when scar tissue is dense and distorts the anatomy. We have found that preoperative placement of a transhepatic tube, leaving the catheter in after a percutaneous transhepatic cholangiogram, is often helpful because you can palpate the tube. But this is controversial because it also decompresses the distended bile ducts to some extent. Would you describe for us your technique for locating the bile duct in difficult recurrent strictures, the ones that we have had the most challenge with? Also why do you believe your success rate was not changed or influenced by the level of the stricture or by the n u m b e r of previous repairs, both of which influenced in a negative way the experience reported from our institution and from most other centers? Dr. Thomas A. Stellato (Cleveland, Ohio). Because the duration of transanastomotic stenting did not seem to influence the outcome, could you c o m m e n t as to which patients you would stent and how long you would leave the stents in place? Dr. Gerald M. I.arson (Louisville, Ky.). Two years ago Dr. Vitale and our group presented to this association our initial experience with ERCP and stenting for strictures that were short and in the distal bile duct. We have expanded our experience and our indications with this now, and using a stenting program that lasts up to 1 year for benign strictures, we have had quite good results. Clearly, in some patients on whom one does not want to operate and in whom the c o m m o n duct is not completely divided the endoscopic approach seems to be attractive. Would you c o m m e n t on the endoscopic approach from your experience? Dr. Farnell (closing). Dr. H e r m a n n asked about our results with primary versus secondary repair. There are basically two reasons why the results observed were no different for the primary and secondary repairs. The Hepp-Couinaud technique is the first reason, in many of the secondary repairs we were able to get proximal to the site of stricture and inflammation and obtain pliable, well vascularized bile duct, which allowed performance of a technically satisfactory anastomosis. The second reason is likely related, at least partially, to selection bias. This is a contemporary series during which alternatives for the management of patients with very complicated proximal strictures were available. Although specific data are not available, it may well be that some of the patients who were not considered good candidates for anatomic reconstruction underwent either endoscopic or percutaneous dilatation, thus biasing favorably our results for secondary reconstructions. Dr. Herman also asked about the use of preoperative stents
McDonald et al.
591
in terms of using the stent to help one localize the bile duct. It is not particularly difficult to find the bile duct if one uses the Hepp-Couinaud technique. The quadrate lobe, segment IV, protects that area from inflammation and scarring and is a very constant anatomic feature. If one uses hilar plate elevation, one can generally find one's way to the bile duct. Having said that, my preference is to have a transhepatic tube placed before operation to avoid the n e e d to place the transhepatic tube during operation. I have not been impressed that the bile duct shrinks that much if preoperative decompression is performed. If a transhepatic tube is not placed before operation, my own preference is to pass a threaded Bakes dilator (Codman, Randolph, Mass.) transhepatically and attach a threaded guide wire. The Seldinger technique is then used to advance a locking catheter transhepatically over the guide wire to gain access to the biliary tree. Dr. Stellato asked about given that the duration of stenting d i d n ' t seem to make any difference, if one leaves stents, then for how long? My personal preference is to leave stents in for about 3 weeks: This time period allows decompression of the anastomosis during perioperative period and performance of postoperative cholangiography. The latter helps one to prognosticate regarding the technical quality of anastomosis. Also, if one is not particularly happy with it for some reason, one still has access to the biliary tree so that intervention can be undertaken, l f o n e is pleased with the anatomic features on cholangiography, then our preference is to remove the tube at 21 days. Dr. Larson asked about endoscopic approaches to partial injuries of the bile duct. Certainly this is gaining increased interest across the country and around the world. I do not have any data on our experience with endoscopic balloon dilatation and stenting. I can c o m m e n t regarding transhepatic stenting. Hugh Williams and colleagues18 of our interventional radiology group reported 74 patients who had partial strictures of the ductal system during a 5-year time period. With a mean follow-up of 28 months, the transhepatic balloon dilatation and stenting failed in 25% of the patients. The mean duration of stenting was about 8 months for those patients. They noted that the rates of infection and bleeding were higher in those patients in whom access to the biliary tree had to be gained by puncturing the liver, whereas those complications were not seen in patients in whom the surgeon had left a transanastomotic stent or a T-tube in place. The point was made that if one anticipates difficulty with one's anastomosis, one should consider providing external access to the biliary tree to facilitate postoperative interventional radiolog~c procedures. Alternatively, there has been interest in placing the afferent portion of the Roux-en-u limb subcutaneously in patients to facilitate access to the biliary tree. This is a very interesting concept, although I cannot c o m m e n t from experience. We have not had an opportunity to utilize the technique as yet.