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Management of recurrent and residual common duct stones
Management of Recurrent and Residual Common Duct Stones
Bruce Allen, MD, San Francisco, California Howard Shapiro, MD, San Francisco, California Lawrence W. Way, MD, San Francisco, California
Although most initial operations for gallstone disease are curative, a small percentage of patients are found at some later date to h a v e additional calculi in t h e duct. T h e s e cases of p o s t c h o l e c y s t e c t o m y choledocho!ithiasis can be divided into three categories: retained stones, residual stones and r e c u r r e n t stones. Retained stones are those detected in the i m m e d i a t e Postoperative period b y T - t u b e cholangiography. Stones found a f t e r w a r d s either m a y have b e e n overlooked at the original operation or m a y h a v e f o r m e d within the d u c t in the interval since t h e original operation. T h e f o r m e r are usually called residual stones a n d the latter r e c u r r e n t stones (or prim a r y common duct stones): Theoretically, the ability to distinguish between residual and recurrent stones has t h e r a p e u t i c implications. For example, p a t i e n t s with residual stones should be cured by choledoc h o l i t h o t o m y alone, whereas p a t i e n t s with continuous stone f o r m a t i o n m a y need a drainage p r o c e d u r e to allow additional stones to pass into the gut. This subject, including the indications for performing a drainage p r o c e d u r e on the c o m m o n duct, has been a m a t t e r of d e b a t e in the surgical literature of the p a s t 20 years. Opinion seems to be divided between those surgeons who p e r f o r m a drainage procedure often and those who do so rarely. Since the merits of the different surgical philosophies should be a p p a r e n t from observing the course of previously t r e a t e d patients, we analyzed the success of various m e t h o d s of treating choledocholithiasis in a group of p a t i e n t s who h a d h a d a previous cholecystectomy. T h e period of the s t u d y s p a n n e d a t i m e w h e n endoscopic sphincterotomy was introduced and gradually b e c a m e the p r o c e d u r e of first choice in the average such patient. Our aim was to answer the following questions a b o u t the t r e a t m e n t of postcholecystect o m y choledocholithiasis: W h a t is the success rate of choledocholithotomy without a drainage procedure? Are there a n y clinical criteria t h a t can be used to identify patients in w h o m recurrent stones are likely From the Departments of Surgery and Medicine, University of California, San Francisco; and the Surgical Service, VA Medical Center, San Francisco, California. Requests for reprints should be addressed to Lawrence W. Way, MD, VA Medical Center, 4150 Clement Street, San Francisco, California 94121. Presented at the 82nd Annual Meeting of the Pacific Coast Surgical Association, Coronado, California, February 15-18, 1981.
Volume 142, July 1981
to develop and thus should have a drainage procedure? Does the addition of a drainage p r o c e d u r e increase the m o r b i d i t y of c h o l e d o c h o l i t h o t o m y ? H o w safe and effective is endoscopic s p h i n c t e r o t o m y c o m p a r e d with surgical t h e r a p y ?
Methods The course of all patients treated for choledocholithiasis presenting after a previous cholecystectomy during the 20 year period, January 1961 to December 1980, at the University of California, San Francisco, was studied. Patients referred for treatment of retained stones (as defined above) were excluded from the study. There were 90 patients whose ages ranged from 31 to 96 years. The interval between the time of the original cholecystectomy and the second biliary tract operation varied from 2 weeks to 46 years. Forty-seven patients were treated surgically. The frequency with which the various types of operations were performed for each recurrence is reported in Table I. Nine of the initial independent choledocholithotomies were performed elsewhere; the remaining 55 operations were performed at our hospital. Endoscopic sphincterotomy was first performed in our institution in 1977. At first it was reserved for patients whose age or other medical problems precluded laparotomy, but in the past year it has become the primary therapy for postcholecystectomy choledocholithiasis regardless of other aspects of the patient's health. Forty-three patients with postcholecystectomy choledocholithiasis were treated by endoscopic sphincterotomy. Recent follow-up information was obtained by telephone interview of 37 (78 percent) of 47 surgically treated patients. The current status of all patients treated by endoscopic sphincter0tomy is known. Because many patients were referred from other hospitals, and because the initial biliary operation had often been performed many years earlier, the details of the operative findings and whether cholangiography or common duct exploration had been performed at the time of ch01ecystectomy were often unavailable. For surgically treated patients, the outcome of each biliary tract operation, the interval between operations, the need for subsequent operations, the operative findings (size of duct, and number and size of ductal stones), and the occurrence of postoperative complications were recorded. We use the term multiple stones to mean more than five stones or stones plus copious amounts of sludge. We defined a failure as an operation that was followed by additional symptoms of biliary disease (cholangitis or jaundice) or by the need for another biliary opera-
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Allen et al
TABLE I
Biliary Tract CholedoOperations cholithot(n) omy (n) 2 3 4 5
16
Type of Operation Performed for Each Recurrence (55 Operations)
30 4 2 0
14
Sphincteroplasty (n)
Choledochojejunostomy (n)
Choledochoduodenostomy (n)
3 2 0 0
1 2 1 2
4 3 1 0
=o C
12
.~_
~
a
.a E z
6
Median=6 years
4
2
tion. In calculating the success rate of choledocholithotomy alone, we excluded operations performed before the patient was referred to Our care. The endoscopic sphincterot0mies were performed with an Olympus JF-B3 sideviewing duodenoscope. Immediately after endoscopic retrograde cholangiography to confirm the diagnosis of choledocholithiasis, an Erlanger type of diathermy sphincterotome was passed deeply and selectively into the common bile duct. Its position was confirmed radiographically, and then, applying a blended diathermy current, a long enough cut (1.0 to 1.8 cm) was made in the sphincter to permit extraction of the stones. In the initial cases we allowed the stones to pass spontaneously. Clearing of the duct was confirmed by follow-up retrograde cholangiography. More recently, we extracted the stones at the time of sphincterotomy with a fiuoroscopically guided balloon-tip catheter or Dormia basket. After a successful uncomplicated sphincterotomy and stone extraction, the patient was observed in the hospital for 2 days and then discharged. For patients treated by endoscopic sphincterotomy, the interval between cholecystectomy and sphincterotomy, the size and number of Stones removed, and the incidence of complications were noted. Sphincterotomy was termed technically unsuccessful when we were unable to incise the sphincter or to remove all the stones. The chi-square test was used to test the significance of differences in failure rates of choledocholithotomy between groups of patients. Results
The mean age of the patients treated surgically was 64 ± 13 years, and was similar to t h a t of patients treated by e n d o s c o p y , 69 ± 14 years. T h e interval between cholecYstectomy and the first procedure for residual or r e c u r r e n t stones is illustrated in Figures i and 2. Surgically t r e a t e d patients are represented in Figure 1, and patients t r e a t e d by endoscopic sphincterotomy in Figure 2. Most (57 percent) of the surgically t r e a t e d patients p r e s e n t e d within 6 years after cholecystectomy, although some patients presented aS late as 30 years afterward. T h e patients t r e a t e d by ~endoscopic s p h i n c t e r o t o m y had had cholecystectomy earlier, 53 percent within 3 years of sphincterotomy. In neither case could the patients be separated into two groups as might be expected if residual stones caused s y m p t o m s soon after cho!ecystectomy and r e c u r r e n t stones formed and became s y m p t o m a t i c over a longer period.
42
4
8
10
20
30
40
50
Years
Figure 1. The Mterval between the initial biliary operation and the first reoperation required for common duct stones for the 47 patients treated surgically.
16 14
12 oz.
10
Median=3 years
8
JQ E Z
6 4 2 4
6
8
10
20
30 40
50
Years
Figure 2. The interval between the initial biliary operation and subsequent endoscopic sphincterotomy for removal of common duct stones in 43 patients.
T h e following variables were t e s t e d to d e t e r m i n e their effect on the likelihood of success of choledoc h o l i t h o t o m y : (1) n u m b e r and size of stones in the duct; (2) the size of the duct; (3) the interval between cholecystectomy and recurrence of ductal stones; (4) the effect of a previous postcholecystectomy choledocholithotomy; (5) the effect of a c o m m o n duct exploration at the time of cholecystectomy; and (6) the effect of a long cystic duct r e m n a n t (greater than 2 cm). Thirty-six choledocholithotomies were performed without a drainage procedure in 34 patients. For the 27 choledocholithotomies for which follow-up was available, the incidence of r e c u r r e n t disease was 33 percent. T h e s e operations can be divided into two subgroups for purposes of analysis: (1) those which h a d been preceded by one or more previous indep e n d e n t choledocholithotomies before our first operation; and (2) those which had been preceded only b y the initial operation (cholecystectomy) for gallstone disease.
The American Journal of Surgery
Recurrent and Residual Common Duct Stones
TABLE II
•
Effect of Duct Size on the Success of Choledocholithotomy (36 Operations) ¢R
Duct Size
Success (n)
Failure (n)
Lost to Follow-Up (n)
Normal 2 cm 3 cm 4 cm Unknown
4 7 3 1 4
1 5 1 1 0
1 6 1
i"
-,c-
]
SUCCESSFUL OUTCOME
[]UNSUCCESSFUL OUTCOME 8
O.
'~
4
,',
2
E z
1"3
4-6
7"15 16-30
Years
Figure 3. The effect of the interval between the first biliary oper-
TABLE III
Effect of the Number of Stones in the Duct on the Success of Choledocholithotomy (36 Operations)
Stones (n)
Success (n)
Failure (n)
Lost to Follow-Up (n)
1 2-5 > 5 or multiple Unknown
9 6 3 1
0 5 2 1
5 1 3 ...
The latter group comprised 20 patients on whom follow-up information could be obtained, only 4 (20 percent) of whom manifested recurrent disease (1 at 1 year; 2 at 2 years; 1 at 5 years). Two patients were definitely shown to have additional Common duct stones and were subsequently treated successfully by a drainage procedure. Two patients had episodes of jaundice or cholangitis but were not operated on. Among the causes for failed choledocholithotomy in these four patients was one case of Clonorchis sinensis infestation of the duct. The duct was dilated and full of sludge, and the contrast medium flowed slowly into the duodenum on the operative cholangiogram. Two of the other three patients had either dilated ducts or multiple stones within tile duct. All three patients had defects on postoperative cholangiograms that suggested the possibility of retained stone (two patients) or stricture (one patient). The mean length of the follow-up of patients who remained asymptomatic was 7.3 :E 5.1 years. The effect of having had a previous independent choledocholithotomy on the outcome of another choledocholithotomy (third or fourth biliary operation) was as follows: Five (83 p e r c e n t ) o f six choledocholithotomies (in four patients) performed as the third or greater biliary operation failed. The difference between the poor success rate of choledocholithotomy in this setting and the low failure rate (20 percent) when choledocholithotomy was performed as the first operation after cholecystectomy is significant (p < 0.01). Seven patients in the surgical group treated by choledocholithotomy alone at our hospital and available for follow-up were known to have had a
Volume 142, July 1981
ation and the first choledocholithotomy on the likelihood of success of choledocholithotomy in 31 patients. Successful Choledocholithofomies are represented by bars with diagonal lines; unsuccessful operations are shown by doffed bar s .
common duct exploration as part of their first operation for gallstone disease, although the results of these previous explorations were unknown. The failure rate of a second choledocholithotomy without a drainage procedure was 14 percent (one of seven) when performed after cholecystectomy that included common duct exploration. Three patients were known to have had cholecystectomy without common duct exploration , and for them choledocholithotomy was curative. Details of the initial operations were unavailable in the remaining 10 patients. Tables I and II show the relation between the size of the duct or the number of stones in the duct and the outcome of all choledocholithotomies. If the duct was of normal caliber or if it contained just one stone, only i of 10 operations was followed by the development of recurrent symptoms. On the other hand, choledocholithotomy was unsuccessful in 7 (39 percent) of 18 patients whose duct contained more than one stone (Table III) or was enlarged ~greater than 2 cm). The size of the stones in the duct did not correlate with the outcome of choledocholithotomy. The results of the initial choledocholithotomy in relation to the interval since previous cholecystectomy are shown in Figure 3. Successes and failures occurred randomly over the 30 year period with no relation to the length of the interval between the first and second operations. The mean time elapsed since cholecystectomy for patients whose choledocholithotomy was unsuccessful was 9.2 ± 7.8 years, whereas 8.2 + 9.2 years had elapsed between cholecystectomy and successful choledocholithotomy. Three patients had a long cystic duct remnant excised at the time of choledocholithotomy, and all did well. One of these patients had had a previous independent choledocholithotomy performed at another hospital, at which time the cystic duct remnant was apparently missed. The principal morbidity of surgical operations was failure to prevent recurrence of choledocholithiasis, which was most often seen in the patients treated by
43
Allen et al
choledocholithotomy alone, including all the operations in our patients for whom follow-up information is available, regardless of whether the operations were performed in our hospital or elsewhere, 14 of the total 31 choledocholithotomies were unsuccessful. Ten of these unsuccessful choledocholithotomies were performed at other hospitals. Seventeen additional operations were performed in these patients: 6 choledocholithotomies and 11 drainage procedures. Of the operations performed at our hospital, one led to the patient's death from a bleeding stress ulcer and aspiration pneumonitis 3 weeks after an unsuccessful attempt to correct biliary obstruction. Only 1 (8 percent) of 14 patients who had a drainage procedure required another biliary operation, and the remainder were asymptomatic after an average of 4.5 + 5 years. The only symptomatic patient had cholangitis caused by accumulation of food in the terminal common duct (sump syndrome). She was treated by revising the choledochoduodenostomy to a Roux-Y choled0chojejunostomy. Endoscopic sphincterotomy was attempted for postcholecystectomy choledocholithiasis in 43 patients ranging in age from 31 to 96 years. There were 37 (86 percent) successful procedures. The ducts in five patients could not be cannulated deep enough to permit sphincterotomy; in one patient the sphincterotomy was technically adequate but all the stones could not be removed from the duct. During the same period, an additional 20 endoscopic sphincterotomies were successfully performed for retained stones. In all, four (8 percent) nonfatal complications occurred during 58 procedures: severe pancreatitis, one patient; hemorrhage requiring transfusion, one patient; and small bowel perforation requiring laparotomy, two patients. Although none of the patients treated by endoscopic sphincterotomy has returned with common duct stones, the follow-up period is only 3 years or less. Comments
Interest in procedures on the common duct to facilitate bile drainage has increased considerably in the past 20 years. Madden et al [1] were early advocates of choledochoduodenostomy, arguing that a high percentage of common duct stones formed primarily within the duct and that a drainage procedure would be necessary to prevent recurrent choledocholithiasis. They claimed that one could distinguish between primary and secondary stones by their gross appearance. Primary stones were earthy, amorphous and crumbly. Such stones were found in the ducts of almost 60 percent of their patients. Saharia et al [2] subsequently tried to test the hypothesis of Madden et al by determining the outcome of a series of patients with postcholecystectomy choledocholithiasis who were treated by choledo/ cholithotomy without a drainage procedure, The
44
study was confined to patients who had been asymptomatic for at least 2 years after the initial biliary procedure in the belief that biliary symptoms that became clinically apparent thereafter were probably due to recurrent rather than residual stones. Other authors have generally accepted this way of distinguishing between recurrent and residual stones. Saharia et al [2] found that choledocholithotomy alone was followed by additional symptoms in only 4 (18 percent) of 22 patients. They concluded that a drainage procedure is seldom indicated for postcholecystectomy choledocholithiasis. In a related report, Braasch et al [3] examined the results of 37 operations in which the common duct stones had the morphologic characteristics of primary stones as defined by Madden et al [1]. In each case the cholecystectomy had been performed at least 2 years before the next operation for choledocholithiasis. Thirty percent of the patients with postcholecystectomy choledocholithiasis whose operation did n o t include a drainage procedure eventually developed additional clinical manifestations of common duct stone disease, leading Braasch et al to conclude that drainage procedures are desirable for this condition. Moreover, the rate of recurrent symptoms was equally high in another group of 40 patients whose stones did not possess these special characteristics, as well as in 17 other patients who presented within 2 years of their first operation. We think that it is questionable whether a cut-off point 2 years after cholecystectomy is a useful benchmark for defining recurrent stone disease. First, patients who have further symptoms do not appear in two clusters, an early group and a late group. Instead, there is a gradual decline in frequency of recurrent symptoms from the early to the late years of follow-up. Undoubtedly, the population with postcholecystectomy choledocholithiasis consists of some with residual and some with recurrent stones, but arbitrarily excluding patients whose symptoms recur within the first 2 years incurs the risk of excluding some of the more severe cases of recurrent stone disease. In Clinical experience it is not uncommon to observe additional stones form over short intervals in patients with uncorrected ductal stasis, and animal studies demonstrate that stasis stones may form within several weeks [4]. Moreover, the assumption that most residual stones would become symptomatic within 2 years is untested and probably incorrect [5]. Finally, neither we nor Braasch et al could identify any characteristics of patients who presented after 2 years that distinguished them from those who presented earlier. Therefore, since residual and recurrent common duct stones probably cannot be differentiated on the basis of indirect evidence, we evaluated the results of treatment of all patients who presented with common duct'stones after cholecystectomy, exclud-
The American Journal of Surgery
Recurrent and Residual Common Duct Stones
ing only those with strictures or retained stones detected on T-tube cholangiography. Our overall failure rate of choledocholithotomy alone for recurrent or residual stone was 33 percent , a rate similar to those reported by others [2,3]. Certain risk factors characterized these failures. Over 80 percent of patients who had had a previous postcholecystectomy choledocholithotomy manifested symptoms after a second choledocholithotomy, and it seems clear that a drainage procedure is strongly indicated in this group. Having had a common duct exploration at the time of cholecystectomy was not associated with a particularly high recurrence rate after a subsequent choledocholithotomy, but our data on this question were incomplete. The risk of recurrence was also increased by the presence of multiple stones or an enlarged duct. We believe these to be relative indications for a drainage procedurel although a substantial number of patients with large ducts or multiple stones did well after choledocholithotomy. The asymptomatic interval between cholecystectomy and recurrence of stones was found unrelated to the success of choledocholithotomy alone. Although our results are similar to those of Saharia et al [2], Our conclusions differ. We feel that their 20 percent recurrence rate within 5 years is a matter of concern, even though the patients were elderly. At present, the life expectancy of men and women aged 65 years in the United States is 14 and 18.4 years, respectively [6]. In their patients the mean interval from the first biliary operation to recurrent symptoms (12 years} was more than twice as long as the average length of follow-up after the second biliary operation (4.75 years), which suggests that more recurrences are bound to appear in these patients within their predicted remaining life span. We do not feel that a drainage procedure is required in all patients with postcholecystectomy choledocholithiasis, however, because certain ones have a very low risk of recurrence. Based on our data, we recommend that a drainage procedure be included as part of an operation for choledocholithiasis if any of the following are present: (1) many stones in the duct, (2) history of a previous choledocholithotomy, or (3) marked dilatation (greater than 2 cm) of the duct, Other indications include (4) inability to remove all stones from the duct, and (5) ductal stricrare. Theoretically, if we had followed these recommendations in each patient with postcholecystectomy choledocholithiasis coming under our care, we would have performed 12 additional drainage procedures, which would have avoided 6 more operations and 2 unoperated failures in 25 patients. Six drainage procedures would have been performed in patients who were, in fact, cured by choledocholith0tomy. Only one patient with an unsuccessful choledochotomy would not have qualified for a drainage procedure by our criteria. Therefore, eight of the nine
Volume 142, July 1981
choledocholithotomy failures in our series could theoretically have been prevented by the selective use of a drainage procedure. Had they been performed, it seems unlikely that these additional drainage procedures would have resulted in morbidity equivalent to the extra operations that resulted from the less aggressive approach. Drainage procedures were highly successful and were performed without significant morbidity or mortality in a small group of patients. In contrast to choledocholithotomy, only i in 14 patients required reoperation after a drainage procedure. Neither our series nor others permit a valid comparison of the various kinds of drainage procedures with regard to efficacy and safety. There are theoretical reasons to favor one procedure over another, but the choice of which procedure to perform is largely based on technical considerations [7]. Sphincteroplasty allows direct inspection of the ampulla and extraction of impacted stones. It can be performed on small ducts (less than 2 cm) without risk of late stricture, b u t carries a greater risk of postoperative pancreatitis than other drainage procedures. Side-to-side choledochoduodenostomy is suitable for common ducts that are larger than 1.5 cm in diameter and offers better decompression of a very large duct than does sphincteroplasty. Occasionally,however, cholangitis or pain develops from accumulation of debris in the terminal bile duct, the "sump" syndrome. For this reason we prefer endto-side choledochoduodenostomy over side-to-side anastomosis when the duct can be easily mobilized from neighboring structures. Roux-Y choledochojejunostomy is also feasible when the duct is dilated. It avoids the risk of the sump syndrome and may diminish the long-term risk of cholangitis, but requires two intestinal anastomoses instead of one. In the past 2 years, most patients with postcholecystectomy choledocholithiasis were treated by endoscopic sphincterotomy; there were 2 operations and 37 sphincterotomies in this period. The success rate was high (86 percent) and the morbidity (7 percent) and mortality (0 percent} low, similar to those reported by others [8,9]. Even if endoscopic sphincterotomy proves to give less complete drainage of the duct than surgical sphincteroplasty, it will be adequate therapy for most patients. So far there is no suggestion that late stricture formation is likely to result. If the disease recurs, the patient can be considered for repeat endoscopic sphincterotomy or surgical drainage of the duct. Initially, because of concern about complications, endoscopic sphincterotomy was reserved for elderly patients or those believed to be at greater than average risk for laparotomy. The ~documented simplicity and success of the procedure has now led us to prefer this mode of therapy over laparotomy and choledocholithotomy. It is occasionally unsuc~cessful and is contraindicated in patients with biliary stricture. In addition, it may
45
Allen et al
be unsafe in some patients with perivaterian duodenal diverticula. We feel t h a t endoscopic sphincte r o t o m y should be offered to all suitable patients with residual or recurrent stones when an experienced endoscopist is available. Summary
W h e n operating on patients with postcholecyst e c t o m y choledocholithiasis, a drainage procedure should be performed for the following indications: (1) multiple stones in the duct, (2) history of choledocholithotomy, (3) m a r k e d dilatation of the duct, (4) inability to remove all stones, and (5) presence of a ductal stricture. P a t i e n t s with none of these are adequately treated by c h o l e d o c h o l i t h o t o m y alone. Because endoscopic sphincterotomy has been shown to be safe and effective, however, it is currently our preferred m e t h o d of t r e a t m e n t for the average patient with this condition.
Acknowledgment: We thank Frenchie Hedgeman, Sheila Finnigan and Dorothy Archbold for their assistance in preparation of the manuscript. References
1. MaddenJL, Vanderheyden L, Kandalaft S. The nature and surgical significance of common duct stones. Surg Gynecol Obstet 1968; 126:3-8. 2. Saharia PC, Zuidema GD, Cameron JL. Primary common duct stones. Ann Surg 1977;185:598-604. 3. Braasch JW, Fender HR, Bonneval MM. Refractory primary common bile duct stone disease. Am J Surg 1980;139: 526-30. 4. Imamoglu K, Yonehiro EG, Perry JF Jr, Wangensteen OH. Formation of calculi following cholecystectomy attending partial occlusions of the common bile duct. Surg Forum 1957;8: 225-9. 5. Way LW. Retained common duct stones. Surg Clin North Am 1974;53:1139-47. 6. Statistical Bulletin 1980;61:13-5. 7. White TT. Indications for sphincteroplasty as opposed to choledochoduodenostomy. Am J Surg 1973; 126:165-70. 8. Nakajima M, Kizu M, Akasaka Y, Kawai K. Five years' experience of endoscopic sphincterotomy in Japan: a collective study from 25 centers. Endoscopy 1979;2:138-41. 9. Cotton PB. Non-operative removal of bile duct stones by duodenoscopic sphincterotomy. Br J Surg 1980;67:1-5. Discussion
Ronald K. Thompkins (Los Angeles, CA): I don't know why the authors have so much difficulty determining whether stones are recurrent or residual. It depends on who did the previous surgery. If it was Dr, Way, I am sure they would all be recurrent stones; if it was someone out of town sending him a patient, they would obviously be retained stones! The authors are to be congratulated on rounding up a series of patients which points out the hazard of management of retained, recurrent, or just common duct stones. The variety of techniques described attests to the fact that there is no good management for all patients. This does not mean that the individual operations are bad; it just means that the patients differ. Some patients are old, some have many stones, and some have strictures; they cover that very nicely in their report.
46
The surgeon needs to have a wide variety of techniques available, including endoscopic papillotomy, which the authors had such success with. There is such a variety of successful techniques for dealing with secondary common duct stones now that there is a danger of surgeons becoming rather complacent, perhaps rather haphazard, in their exploration of the common duct, the idea being that if it takes a little too long or if something is not working out quite right, you can put in a large T tube and later turn it over to the radiologist or someone with some chemicals to dissolve it. We would prefer that surgeons sharpen their skills, use all the implements available in the operating room, and do a proper procedure the first time. We must emphasize preventative measures for common duct stones rather than these remedial techniques which have such varied success. These include operative palpation, operarive cholangiography and choledochoscopy if the common duct is open. If these techniques are used thoroughly and in combination, it should result in less than a I percent rate of so-called residual common duct stones. The message I received from this study is to try to prevent this problem rather than to try to find different ways to deal with it. I wonder whether the authors have looked at how many of the patients with common duct stones in their series had operative cholangiography at the time of the original surgery. Excluding the 46 year follow-up patient but including the more recent stones you found, how many had operative cholangiography, and what were the results? Did the authors calculate the cost of treatment of the average patient with retained stones: that is, operative treatment versus endoscopic papillotomy? We hear a lot about the cost-effectiveness of various techniques. Several criticisms have been leveled at routine cystic duct cholangiography, but those who analyze the cost fail to take into account that the true cost of routine cholangiography is the cost of the cholangiogram itself with all the time required. There has to be subtracted from that the cost what was saved by n o t having to treat 5 to 7 percent of patients with unsuspected common duct stones who otherwise would come in for this type of expensive treatment, patients whom the authors have talked about. That is the true cost of routine cholangiography, and it is much lower than the published figures. Wilton Doane (Santa Barbara, CA): One of the very important things in preventing retained or recurrent duct stones is adequate operative cholangiography at the time of the initial operation on the gallbladder. I recently examined cholangiograms at the Cottage Hospital and found some amazing ones. Of the 56 cases I examined, 14, or 25 percent, required more than two pictures, and I think that most of us should be able to get adequate visualization with two pictures. Roentgenographic penetration and contrast quality were not a problem. Blurring due to motion was a problem in 14 percent. Poor positioning accounted for 21 percent and air bubbles in 36 percent, but the most important factor is the quantity of contrast material. I designed a double lumen cholangiographic catheter with a balloon at the end that is produced by Edwards Laboratories. Dye in the balloon is passed through the cystic duct into the duodenum, inflated and pulled back. With dye injected through the second lumen, one gets controlled filling of the common duct, permitting better filling of the common duct and hepatic radicals. I use about
The American Journal of Surgery
Recurrent and Residual Common Duct Stones
10 cc in the initial ifljection with the balloon pulled back. On the second injection 15 cc is used, showing good emptying into the duodenum and good filling. I am not saying t h a t all my films are excellent, b u t one can do it with fair consistency, and I think it is worth considering. T h o m a s T. W h i t e (Seattle, WA): I certainly agree with Drs. Tompkins and Doane t h a t proper roentgenography, choledochoscopy and even pressure measurements may be useful in preventing recurrence. I think, however, t h a t if all the roentgenographs are as opaque as Dr. Doane's, you probably could not see any stones at all. Second, some workers do choledochoscopy intraoperatively without obtaining a completion cholangiogram. The roentgenograph taken several days later shows a residual stone. The authors are quite clear in pointing out t h a t there is a high failure rate after reexploration tbr recurrent or residual stones and t h a t endoscopic sphincterotomy might offer less morbidity and mortality than reoperation. Follow-up is required before we know whether or not these patients are going to have recurrence. I would like to know how long a n e n d o s c 0 p i c cut was made in the sphincter. W h e n we started, in the late 1940s at Bellevue Hospital, we made 8 m m sphincterotomies and they obstructed. I would like to reemphasize t h a t not everyone is as skillful as Dr. Shapiro. W h e n I talked to Professor Fric, head of gastroenterology at Prague, he said t h a t after a Czech endoscopist has done 600 endoscopic retrograde cholangiopancreatographies, then he may try sphincterotomy. I know Dr. Shapiro has done at least t h a t number; maybe we should defer to colleagues like him when we have this type of procedure done. H i r a m H. B e l d i n g I I I (Riverside, CA): I would like to emphasize the statements about how important initial exploration of the common duct is rather than relying too much on cholangiography. It was my privilege to be trained for 1 year by Dr. Waltman Walters, who ritualistically showed how to explore the common duct, and the way the common duct was explored by him was over and over and over again. The incision was made in the common duct. It was first flushed out very carefully. Scoops were used. I t was flushed. Scoops were used, before the sphincter was ever dilated, and it was always amazing to me that one more time brought that little stone out of the ampulla. At t h a t time, we were not using cholangiography, and I think we had about the same accuracy. All of us are familiar with the air bubble we get from the cholangiogram, which is disconcerting. We have seen, I believe, as many errors with cholangiography as with careful exploration. H o w a r d S h a p i r o (San Francisco, CA): This is strange territory for an internist to invade, but I wanted to be here particularly to get some feedback on this study, and I am delighted to see t h a t no one was terribly vehement about defending his territory, namely the surgical t r e a t m e n t of retained or recurrent common duct stones. I think t h a t Dr. Allen gave a very nice discussion of the material we have all worked on together, but I do want to respond briefly to Dr. T o m p k i n s ' s theory about the costeffectiveness of endoscopic sphincterotomy versus secondary Choledochotomy with or without a drainage procedure.
Volume 142, July 1981
Our patients generally are brought into the hospital when we do endoscopic sphincterotomy. On the first hospital day they get diagnostic retrograde cholangiography and at the same sitting t h a t endoscopic sphincterotomy and stone extraction take place. The patients are generally observed for 48 hours thereafter and then sent home with unlimited activities and no convalescent time whatsoever. That is a 3 day hospital stay for endoscopic sphincterotomy and stone extraction. I think this compares favorably with the time t h a t is taken to do secondary choledoehotomy. L a w r e n c e W. W a y (closing): We did not plan in this study to address the question Of retained stones, although it is impossible to separate completely t h a t issue from the one at hand. In this report we concentrated on the patient who is discovered to have additional disease late after the initial biliary operation. Nevertheless, comments in regard to prevention are pertinent. Prevention requires a multifaceted diagnostic approach at the time of the original choledochotomy. Precision in performing common duct exploration, choledochoscopy and completion cholangiography are the principal means of avoiding retained stones. All the evidence to date suggests t h a t the three techniques supplement each other, and no one of them can be relied upon alone for optimal results. However, the main objectives of this study were (1) to determine when to perform a drainage procedure when operating on a patient with postcholecystectomy cho]edocholithiasis, and (2) to assess endoscopic sphincterotomy as an alternative to surgery. Our data led us to conclude that previous analyses of the indications for a drainage procedure were polarized; some surgeons would use a drainage procedure in a majority of patients, while others would do so rarely. Our experience demonstrates it is possible to identify specific patients who are at high risk for recurrent disease if a drainage procedure is not performed, and t h a t it is unnecessary to perform a drainage procedure in the remainder (the majority). However, endoscopic sphincterotomy has b e e n so successful t h a t we now consider it preferable to laparotomy in most patients with recurrent and residual stones. Initially, there were questions of efficacy and safety. But the complication rate has been acceptable, and the procedure has freed the duct of stones in a high percentage of cases. We agree with Dr. White that the judgment is not final; more time must pass before the risks of recurrent stones and late restenosis are known. So far, however, it appears that the sphincterotomy remains patent, although we have not systematically studied this point. For example, there has been no instance of late recurrent cholangitis, and in the few patients given barium many months after sphincterotomy, it refluxed into the bile ducts. From the standpoint of direct (hospital and physician) and indirect (from time off work) costs, sphincterotomy has a clear-cut advantage over surgery. It is i m p o r t a n t to emphasize Dr. White's point t h a t endoscopists are incapable of performing endoscopic sphincterotomy with the requisite safety and success without special training. Dr. Shapiro, for example, spent 3 months studying this technique at another institution before performing his first procedure in San Francisco. Good success and low complication rates can be expected only when this approach is followed.
47
Bruce Allen, MD, San Francisco, California Howard Shapiro, MD, San Francisco, California Lawrence W. Way, MD, San Francisco, California
Although most initial operations for gallstone disease are curative, a small percentage of patients are found at some later date to h a v e additional calculi in t h e duct. T h e s e cases of p o s t c h o l e c y s t e c t o m y choledocho!ithiasis can be divided into three categories: retained stones, residual stones and r e c u r r e n t stones. Retained stones are those detected in the i m m e d i a t e Postoperative period b y T - t u b e cholangiography. Stones found a f t e r w a r d s either m a y have b e e n overlooked at the original operation or m a y h a v e f o r m e d within the d u c t in the interval since t h e original operation. T h e f o r m e r are usually called residual stones a n d the latter r e c u r r e n t stones (or prim a r y common duct stones): Theoretically, the ability to distinguish between residual and recurrent stones has t h e r a p e u t i c implications. For example, p a t i e n t s with residual stones should be cured by choledoc h o l i t h o t o m y alone, whereas p a t i e n t s with continuous stone f o r m a t i o n m a y need a drainage p r o c e d u r e to allow additional stones to pass into the gut. This subject, including the indications for performing a drainage p r o c e d u r e on the c o m m o n duct, has been a m a t t e r of d e b a t e in the surgical literature of the p a s t 20 years. Opinion seems to be divided between those surgeons who p e r f o r m a drainage procedure often and those who do so rarely. Since the merits of the different surgical philosophies should be a p p a r e n t from observing the course of previously t r e a t e d patients, we analyzed the success of various m e t h o d s of treating choledocholithiasis in a group of p a t i e n t s who h a d h a d a previous cholecystectomy. T h e period of the s t u d y s p a n n e d a t i m e w h e n endoscopic sphincterotomy was introduced and gradually b e c a m e the p r o c e d u r e of first choice in the average such patient. Our aim was to answer the following questions a b o u t the t r e a t m e n t of postcholecystect o m y choledocholithiasis: W h a t is the success rate of choledocholithotomy without a drainage procedure? Are there a n y clinical criteria t h a t can be used to identify patients in w h o m recurrent stones are likely From the Departments of Surgery and Medicine, University of California, San Francisco; and the Surgical Service, VA Medical Center, San Francisco, California. Requests for reprints should be addressed to Lawrence W. Way, MD, VA Medical Center, 4150 Clement Street, San Francisco, California 94121. Presented at the 82nd Annual Meeting of the Pacific Coast Surgical Association, Coronado, California, February 15-18, 1981.
Volume 142, July 1981
to develop and thus should have a drainage procedure? Does the addition of a drainage p r o c e d u r e increase the m o r b i d i t y of c h o l e d o c h o l i t h o t o m y ? H o w safe and effective is endoscopic s p h i n c t e r o t o m y c o m p a r e d with surgical t h e r a p y ?
Methods The course of all patients treated for choledocholithiasis presenting after a previous cholecystectomy during the 20 year period, January 1961 to December 1980, at the University of California, San Francisco, was studied. Patients referred for treatment of retained stones (as defined above) were excluded from the study. There were 90 patients whose ages ranged from 31 to 96 years. The interval between the time of the original cholecystectomy and the second biliary tract operation varied from 2 weeks to 46 years. Forty-seven patients were treated surgically. The frequency with which the various types of operations were performed for each recurrence is reported in Table I. Nine of the initial independent choledocholithotomies were performed elsewhere; the remaining 55 operations were performed at our hospital. Endoscopic sphincterotomy was first performed in our institution in 1977. At first it was reserved for patients whose age or other medical problems precluded laparotomy, but in the past year it has become the primary therapy for postcholecystectomy choledocholithiasis regardless of other aspects of the patient's health. Forty-three patients with postcholecystectomy choledocholithiasis were treated by endoscopic sphincterotomy. Recent follow-up information was obtained by telephone interview of 37 (78 percent) of 47 surgically treated patients. The current status of all patients treated by endoscopic sphincter0tomy is known. Because many patients were referred from other hospitals, and because the initial biliary operation had often been performed many years earlier, the details of the operative findings and whether cholangiography or common duct exploration had been performed at the time of ch01ecystectomy were often unavailable. For surgically treated patients, the outcome of each biliary tract operation, the interval between operations, the need for subsequent operations, the operative findings (size of duct, and number and size of ductal stones), and the occurrence of postoperative complications were recorded. We use the term multiple stones to mean more than five stones or stones plus copious amounts of sludge. We defined a failure as an operation that was followed by additional symptoms of biliary disease (cholangitis or jaundice) or by the need for another biliary opera-
,41
Allen et al
TABLE I
Biliary Tract CholedoOperations cholithot(n) omy (n) 2 3 4 5
16
Type of Operation Performed for Each Recurrence (55 Operations)
30 4 2 0
14
Sphincteroplasty (n)
Choledochojejunostomy (n)
Choledochoduodenostomy (n)
3 2 0 0
1 2 1 2
4 3 1 0
=o C
12
.~_
~
a
.a E z
6
Median=6 years
4
2
tion. In calculating the success rate of choledocholithotomy alone, we excluded operations performed before the patient was referred to Our care. The endoscopic sphincterot0mies were performed with an Olympus JF-B3 sideviewing duodenoscope. Immediately after endoscopic retrograde cholangiography to confirm the diagnosis of choledocholithiasis, an Erlanger type of diathermy sphincterotome was passed deeply and selectively into the common bile duct. Its position was confirmed radiographically, and then, applying a blended diathermy current, a long enough cut (1.0 to 1.8 cm) was made in the sphincter to permit extraction of the stones. In the initial cases we allowed the stones to pass spontaneously. Clearing of the duct was confirmed by follow-up retrograde cholangiography. More recently, we extracted the stones at the time of sphincterotomy with a fiuoroscopically guided balloon-tip catheter or Dormia basket. After a successful uncomplicated sphincterotomy and stone extraction, the patient was observed in the hospital for 2 days and then discharged. For patients treated by endoscopic sphincterotomy, the interval between cholecystectomy and sphincterotomy, the size and number of Stones removed, and the incidence of complications were noted. Sphincterotomy was termed technically unsuccessful when we were unable to incise the sphincter or to remove all the stones. The chi-square test was used to test the significance of differences in failure rates of choledocholithotomy between groups of patients. Results
The mean age of the patients treated surgically was 64 ± 13 years, and was similar to t h a t of patients treated by e n d o s c o p y , 69 ± 14 years. T h e interval between cholecYstectomy and the first procedure for residual or r e c u r r e n t stones is illustrated in Figures i and 2. Surgically t r e a t e d patients are represented in Figure 1, and patients t r e a t e d by endoscopic sphincterotomy in Figure 2. Most (57 percent) of the surgically t r e a t e d patients p r e s e n t e d within 6 years after cholecystectomy, although some patients presented aS late as 30 years afterward. T h e patients t r e a t e d by ~endoscopic s p h i n c t e r o t o m y had had cholecystectomy earlier, 53 percent within 3 years of sphincterotomy. In neither case could the patients be separated into two groups as might be expected if residual stones caused s y m p t o m s soon after cho!ecystectomy and r e c u r r e n t stones formed and became s y m p t o m a t i c over a longer period.
42
4
8
10
20
30
40
50
Years
Figure 1. The Mterval between the initial biliary operation and the first reoperation required for common duct stones for the 47 patients treated surgically.
16 14
12 oz.
10
Median=3 years
8
JQ E Z
6 4 2 4
6
8
10
20
30 40
50
Years
Figure 2. The interval between the initial biliary operation and subsequent endoscopic sphincterotomy for removal of common duct stones in 43 patients.
T h e following variables were t e s t e d to d e t e r m i n e their effect on the likelihood of success of choledoc h o l i t h o t o m y : (1) n u m b e r and size of stones in the duct; (2) the size of the duct; (3) the interval between cholecystectomy and recurrence of ductal stones; (4) the effect of a previous postcholecystectomy choledocholithotomy; (5) the effect of a c o m m o n duct exploration at the time of cholecystectomy; and (6) the effect of a long cystic duct r e m n a n t (greater than 2 cm). Thirty-six choledocholithotomies were performed without a drainage procedure in 34 patients. For the 27 choledocholithotomies for which follow-up was available, the incidence of r e c u r r e n t disease was 33 percent. T h e s e operations can be divided into two subgroups for purposes of analysis: (1) those which h a d been preceded by one or more previous indep e n d e n t choledocholithotomies before our first operation; and (2) those which had been preceded only b y the initial operation (cholecystectomy) for gallstone disease.
The American Journal of Surgery
Recurrent and Residual Common Duct Stones
TABLE II
•
Effect of Duct Size on the Success of Choledocholithotomy (36 Operations) ¢R
Duct Size
Success (n)
Failure (n)
Lost to Follow-Up (n)
Normal 2 cm 3 cm 4 cm Unknown
4 7 3 1 4
1 5 1 1 0
1 6 1
i"
-,c-
]
SUCCESSFUL OUTCOME
[]UNSUCCESSFUL OUTCOME 8
O.
'~
4
,',
2
E z
1"3
4-6
7"15 16-30
Years
Figure 3. The effect of the interval between the first biliary oper-
TABLE III
Effect of the Number of Stones in the Duct on the Success of Choledocholithotomy (36 Operations)
Stones (n)
Success (n)
Failure (n)
Lost to Follow-Up (n)
1 2-5 > 5 or multiple Unknown
9 6 3 1
0 5 2 1
5 1 3 ...
The latter group comprised 20 patients on whom follow-up information could be obtained, only 4 (20 percent) of whom manifested recurrent disease (1 at 1 year; 2 at 2 years; 1 at 5 years). Two patients were definitely shown to have additional Common duct stones and were subsequently treated successfully by a drainage procedure. Two patients had episodes of jaundice or cholangitis but were not operated on. Among the causes for failed choledocholithotomy in these four patients was one case of Clonorchis sinensis infestation of the duct. The duct was dilated and full of sludge, and the contrast medium flowed slowly into the duodenum on the operative cholangiogram. Two of the other three patients had either dilated ducts or multiple stones within tile duct. All three patients had defects on postoperative cholangiograms that suggested the possibility of retained stone (two patients) or stricture (one patient). The mean length of the follow-up of patients who remained asymptomatic was 7.3 :E 5.1 years. The effect of having had a previous independent choledocholithotomy on the outcome of another choledocholithotomy (third or fourth biliary operation) was as follows: Five (83 p e r c e n t ) o f six choledocholithotomies (in four patients) performed as the third or greater biliary operation failed. The difference between the poor success rate of choledocholithotomy in this setting and the low failure rate (20 percent) when choledocholithotomy was performed as the first operation after cholecystectomy is significant (p < 0.01). Seven patients in the surgical group treated by choledocholithotomy alone at our hospital and available for follow-up were known to have had a
Volume 142, July 1981
ation and the first choledocholithotomy on the likelihood of success of choledocholithotomy in 31 patients. Successful Choledocholithofomies are represented by bars with diagonal lines; unsuccessful operations are shown by doffed bar s .
common duct exploration as part of their first operation for gallstone disease, although the results of these previous explorations were unknown. The failure rate of a second choledocholithotomy without a drainage procedure was 14 percent (one of seven) when performed after cholecystectomy that included common duct exploration. Three patients were known to have had cholecystectomy without common duct exploration , and for them choledocholithotomy was curative. Details of the initial operations were unavailable in the remaining 10 patients. Tables I and II show the relation between the size of the duct or the number of stones in the duct and the outcome of all choledocholithotomies. If the duct was of normal caliber or if it contained just one stone, only i of 10 operations was followed by the development of recurrent symptoms. On the other hand, choledocholithotomy was unsuccessful in 7 (39 percent) of 18 patients whose duct contained more than one stone (Table III) or was enlarged ~greater than 2 cm). The size of the stones in the duct did not correlate with the outcome of choledocholithotomy. The results of the initial choledocholithotomy in relation to the interval since previous cholecystectomy are shown in Figure 3. Successes and failures occurred randomly over the 30 year period with no relation to the length of the interval between the first and second operations. The mean time elapsed since cholecystectomy for patients whose choledocholithotomy was unsuccessful was 9.2 ± 7.8 years, whereas 8.2 + 9.2 years had elapsed between cholecystectomy and successful choledocholithotomy. Three patients had a long cystic duct remnant excised at the time of choledocholithotomy, and all did well. One of these patients had had a previous independent choledocholithotomy performed at another hospital, at which time the cystic duct remnant was apparently missed. The principal morbidity of surgical operations was failure to prevent recurrence of choledocholithiasis, which was most often seen in the patients treated by
43
Allen et al
choledocholithotomy alone, including all the operations in our patients for whom follow-up information is available, regardless of whether the operations were performed in our hospital or elsewhere, 14 of the total 31 choledocholithotomies were unsuccessful. Ten of these unsuccessful choledocholithotomies were performed at other hospitals. Seventeen additional operations were performed in these patients: 6 choledocholithotomies and 11 drainage procedures. Of the operations performed at our hospital, one led to the patient's death from a bleeding stress ulcer and aspiration pneumonitis 3 weeks after an unsuccessful attempt to correct biliary obstruction. Only 1 (8 percent) of 14 patients who had a drainage procedure required another biliary operation, and the remainder were asymptomatic after an average of 4.5 + 5 years. The only symptomatic patient had cholangitis caused by accumulation of food in the terminal common duct (sump syndrome). She was treated by revising the choledochoduodenostomy to a Roux-Y choled0chojejunostomy. Endoscopic sphincterotomy was attempted for postcholecystectomy choledocholithiasis in 43 patients ranging in age from 31 to 96 years. There were 37 (86 percent) successful procedures. The ducts in five patients could not be cannulated deep enough to permit sphincterotomy; in one patient the sphincterotomy was technically adequate but all the stones could not be removed from the duct. During the same period, an additional 20 endoscopic sphincterotomies were successfully performed for retained stones. In all, four (8 percent) nonfatal complications occurred during 58 procedures: severe pancreatitis, one patient; hemorrhage requiring transfusion, one patient; and small bowel perforation requiring laparotomy, two patients. Although none of the patients treated by endoscopic sphincterotomy has returned with common duct stones, the follow-up period is only 3 years or less. Comments
Interest in procedures on the common duct to facilitate bile drainage has increased considerably in the past 20 years. Madden et al [1] were early advocates of choledochoduodenostomy, arguing that a high percentage of common duct stones formed primarily within the duct and that a drainage procedure would be necessary to prevent recurrent choledocholithiasis. They claimed that one could distinguish between primary and secondary stones by their gross appearance. Primary stones were earthy, amorphous and crumbly. Such stones were found in the ducts of almost 60 percent of their patients. Saharia et al [2] subsequently tried to test the hypothesis of Madden et al by determining the outcome of a series of patients with postcholecystectomy choledocholithiasis who were treated by choledo/ cholithotomy without a drainage procedure, The
44
study was confined to patients who had been asymptomatic for at least 2 years after the initial biliary procedure in the belief that biliary symptoms that became clinically apparent thereafter were probably due to recurrent rather than residual stones. Other authors have generally accepted this way of distinguishing between recurrent and residual stones. Saharia et al [2] found that choledocholithotomy alone was followed by additional symptoms in only 4 (18 percent) of 22 patients. They concluded that a drainage procedure is seldom indicated for postcholecystectomy choledocholithiasis. In a related report, Braasch et al [3] examined the results of 37 operations in which the common duct stones had the morphologic characteristics of primary stones as defined by Madden et al [1]. In each case the cholecystectomy had been performed at least 2 years before the next operation for choledocholithiasis. Thirty percent of the patients with postcholecystectomy choledocholithiasis whose operation did n o t include a drainage procedure eventually developed additional clinical manifestations of common duct stone disease, leading Braasch et al to conclude that drainage procedures are desirable for this condition. Moreover, the rate of recurrent symptoms was equally high in another group of 40 patients whose stones did not possess these special characteristics, as well as in 17 other patients who presented within 2 years of their first operation. We think that it is questionable whether a cut-off point 2 years after cholecystectomy is a useful benchmark for defining recurrent stone disease. First, patients who have further symptoms do not appear in two clusters, an early group and a late group. Instead, there is a gradual decline in frequency of recurrent symptoms from the early to the late years of follow-up. Undoubtedly, the population with postcholecystectomy choledocholithiasis consists of some with residual and some with recurrent stones, but arbitrarily excluding patients whose symptoms recur within the first 2 years incurs the risk of excluding some of the more severe cases of recurrent stone disease. In Clinical experience it is not uncommon to observe additional stones form over short intervals in patients with uncorrected ductal stasis, and animal studies demonstrate that stasis stones may form within several weeks [4]. Moreover, the assumption that most residual stones would become symptomatic within 2 years is untested and probably incorrect [5]. Finally, neither we nor Braasch et al could identify any characteristics of patients who presented after 2 years that distinguished them from those who presented earlier. Therefore, since residual and recurrent common duct stones probably cannot be differentiated on the basis of indirect evidence, we evaluated the results of treatment of all patients who presented with common duct'stones after cholecystectomy, exclud-
The American Journal of Surgery
Recurrent and Residual Common Duct Stones
ing only those with strictures or retained stones detected on T-tube cholangiography. Our overall failure rate of choledocholithotomy alone for recurrent or residual stone was 33 percent , a rate similar to those reported by others [2,3]. Certain risk factors characterized these failures. Over 80 percent of patients who had had a previous postcholecystectomy choledocholithotomy manifested symptoms after a second choledocholithotomy, and it seems clear that a drainage procedure is strongly indicated in this group. Having had a common duct exploration at the time of cholecystectomy was not associated with a particularly high recurrence rate after a subsequent choledocholithotomy, but our data on this question were incomplete. The risk of recurrence was also increased by the presence of multiple stones or an enlarged duct. We believe these to be relative indications for a drainage procedurel although a substantial number of patients with large ducts or multiple stones did well after choledocholithotomy. The asymptomatic interval between cholecystectomy and recurrence of stones was found unrelated to the success of choledocholithotomy alone. Although our results are similar to those of Saharia et al [2], Our conclusions differ. We feel that their 20 percent recurrence rate within 5 years is a matter of concern, even though the patients were elderly. At present, the life expectancy of men and women aged 65 years in the United States is 14 and 18.4 years, respectively [6]. In their patients the mean interval from the first biliary operation to recurrent symptoms (12 years} was more than twice as long as the average length of follow-up after the second biliary operation (4.75 years), which suggests that more recurrences are bound to appear in these patients within their predicted remaining life span. We do not feel that a drainage procedure is required in all patients with postcholecystectomy choledocholithiasis, however, because certain ones have a very low risk of recurrence. Based on our data, we recommend that a drainage procedure be included as part of an operation for choledocholithiasis if any of the following are present: (1) many stones in the duct, (2) history of a previous choledocholithotomy, or (3) marked dilatation (greater than 2 cm) of the duct, Other indications include (4) inability to remove all stones from the duct, and (5) ductal stricrare. Theoretically, if we had followed these recommendations in each patient with postcholecystectomy choledocholithiasis coming under our care, we would have performed 12 additional drainage procedures, which would have avoided 6 more operations and 2 unoperated failures in 25 patients. Six drainage procedures would have been performed in patients who were, in fact, cured by choledocholith0tomy. Only one patient with an unsuccessful choledochotomy would not have qualified for a drainage procedure by our criteria. Therefore, eight of the nine
Volume 142, July 1981
choledocholithotomy failures in our series could theoretically have been prevented by the selective use of a drainage procedure. Had they been performed, it seems unlikely that these additional drainage procedures would have resulted in morbidity equivalent to the extra operations that resulted from the less aggressive approach. Drainage procedures were highly successful and were performed without significant morbidity or mortality in a small group of patients. In contrast to choledocholithotomy, only i in 14 patients required reoperation after a drainage procedure. Neither our series nor others permit a valid comparison of the various kinds of drainage procedures with regard to efficacy and safety. There are theoretical reasons to favor one procedure over another, but the choice of which procedure to perform is largely based on technical considerations [7]. Sphincteroplasty allows direct inspection of the ampulla and extraction of impacted stones. It can be performed on small ducts (less than 2 cm) without risk of late stricture, b u t carries a greater risk of postoperative pancreatitis than other drainage procedures. Side-to-side choledochoduodenostomy is suitable for common ducts that are larger than 1.5 cm in diameter and offers better decompression of a very large duct than does sphincteroplasty. Occasionally,however, cholangitis or pain develops from accumulation of debris in the terminal bile duct, the "sump" syndrome. For this reason we prefer endto-side choledochoduodenostomy over side-to-side anastomosis when the duct can be easily mobilized from neighboring structures. Roux-Y choledochojejunostomy is also feasible when the duct is dilated. It avoids the risk of the sump syndrome and may diminish the long-term risk of cholangitis, but requires two intestinal anastomoses instead of one. In the past 2 years, most patients with postcholecystectomy choledocholithiasis were treated by endoscopic sphincterotomy; there were 2 operations and 37 sphincterotomies in this period. The success rate was high (86 percent) and the morbidity (7 percent) and mortality (0 percent} low, similar to those reported by others [8,9]. Even if endoscopic sphincterotomy proves to give less complete drainage of the duct than surgical sphincteroplasty, it will be adequate therapy for most patients. So far there is no suggestion that late stricture formation is likely to result. If the disease recurs, the patient can be considered for repeat endoscopic sphincterotomy or surgical drainage of the duct. Initially, because of concern about complications, endoscopic sphincterotomy was reserved for elderly patients or those believed to be at greater than average risk for laparotomy. The ~documented simplicity and success of the procedure has now led us to prefer this mode of therapy over laparotomy and choledocholithotomy. It is occasionally unsuc~cessful and is contraindicated in patients with biliary stricture. In addition, it may
45
Allen et al
be unsafe in some patients with perivaterian duodenal diverticula. We feel t h a t endoscopic sphincte r o t o m y should be offered to all suitable patients with residual or recurrent stones when an experienced endoscopist is available. Summary
W h e n operating on patients with postcholecyst e c t o m y choledocholithiasis, a drainage procedure should be performed for the following indications: (1) multiple stones in the duct, (2) history of choledocholithotomy, (3) m a r k e d dilatation of the duct, (4) inability to remove all stones, and (5) presence of a ductal stricture. P a t i e n t s with none of these are adequately treated by c h o l e d o c h o l i t h o t o m y alone. Because endoscopic sphincterotomy has been shown to be safe and effective, however, it is currently our preferred m e t h o d of t r e a t m e n t for the average patient with this condition.
Acknowledgment: We thank Frenchie Hedgeman, Sheila Finnigan and Dorothy Archbold for their assistance in preparation of the manuscript. References
1. MaddenJL, Vanderheyden L, Kandalaft S. The nature and surgical significance of common duct stones. Surg Gynecol Obstet 1968; 126:3-8. 2. Saharia PC, Zuidema GD, Cameron JL. Primary common duct stones. Ann Surg 1977;185:598-604. 3. Braasch JW, Fender HR, Bonneval MM. Refractory primary common bile duct stone disease. Am J Surg 1980;139: 526-30. 4. Imamoglu K, Yonehiro EG, Perry JF Jr, Wangensteen OH. Formation of calculi following cholecystectomy attending partial occlusions of the common bile duct. Surg Forum 1957;8: 225-9. 5. Way LW. Retained common duct stones. Surg Clin North Am 1974;53:1139-47. 6. Statistical Bulletin 1980;61:13-5. 7. White TT. Indications for sphincteroplasty as opposed to choledochoduodenostomy. Am J Surg 1973; 126:165-70. 8. Nakajima M, Kizu M, Akasaka Y, Kawai K. Five years' experience of endoscopic sphincterotomy in Japan: a collective study from 25 centers. Endoscopy 1979;2:138-41. 9. Cotton PB. Non-operative removal of bile duct stones by duodenoscopic sphincterotomy. Br J Surg 1980;67:1-5. Discussion
Ronald K. Thompkins (Los Angeles, CA): I don't know why the authors have so much difficulty determining whether stones are recurrent or residual. It depends on who did the previous surgery. If it was Dr, Way, I am sure they would all be recurrent stones; if it was someone out of town sending him a patient, they would obviously be retained stones! The authors are to be congratulated on rounding up a series of patients which points out the hazard of management of retained, recurrent, or just common duct stones. The variety of techniques described attests to the fact that there is no good management for all patients. This does not mean that the individual operations are bad; it just means that the patients differ. Some patients are old, some have many stones, and some have strictures; they cover that very nicely in their report.
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The surgeon needs to have a wide variety of techniques available, including endoscopic papillotomy, which the authors had such success with. There is such a variety of successful techniques for dealing with secondary common duct stones now that there is a danger of surgeons becoming rather complacent, perhaps rather haphazard, in their exploration of the common duct, the idea being that if it takes a little too long or if something is not working out quite right, you can put in a large T tube and later turn it over to the radiologist or someone with some chemicals to dissolve it. We would prefer that surgeons sharpen their skills, use all the implements available in the operating room, and do a proper procedure the first time. We must emphasize preventative measures for common duct stones rather than these remedial techniques which have such varied success. These include operative palpation, operarive cholangiography and choledochoscopy if the common duct is open. If these techniques are used thoroughly and in combination, it should result in less than a I percent rate of so-called residual common duct stones. The message I received from this study is to try to prevent this problem rather than to try to find different ways to deal with it. I wonder whether the authors have looked at how many of the patients with common duct stones in their series had operative cholangiography at the time of the original surgery. Excluding the 46 year follow-up patient but including the more recent stones you found, how many had operative cholangiography, and what were the results? Did the authors calculate the cost of treatment of the average patient with retained stones: that is, operative treatment versus endoscopic papillotomy? We hear a lot about the cost-effectiveness of various techniques. Several criticisms have been leveled at routine cystic duct cholangiography, but those who analyze the cost fail to take into account that the true cost of routine cholangiography is the cost of the cholangiogram itself with all the time required. There has to be subtracted from that the cost what was saved by n o t having to treat 5 to 7 percent of patients with unsuspected common duct stones who otherwise would come in for this type of expensive treatment, patients whom the authors have talked about. That is the true cost of routine cholangiography, and it is much lower than the published figures. Wilton Doane (Santa Barbara, CA): One of the very important things in preventing retained or recurrent duct stones is adequate operative cholangiography at the time of the initial operation on the gallbladder. I recently examined cholangiograms at the Cottage Hospital and found some amazing ones. Of the 56 cases I examined, 14, or 25 percent, required more than two pictures, and I think that most of us should be able to get adequate visualization with two pictures. Roentgenographic penetration and contrast quality were not a problem. Blurring due to motion was a problem in 14 percent. Poor positioning accounted for 21 percent and air bubbles in 36 percent, but the most important factor is the quantity of contrast material. I designed a double lumen cholangiographic catheter with a balloon at the end that is produced by Edwards Laboratories. Dye in the balloon is passed through the cystic duct into the duodenum, inflated and pulled back. With dye injected through the second lumen, one gets controlled filling of the common duct, permitting better filling of the common duct and hepatic radicals. I use about
The American Journal of Surgery
Recurrent and Residual Common Duct Stones
10 cc in the initial ifljection with the balloon pulled back. On the second injection 15 cc is used, showing good emptying into the duodenum and good filling. I am not saying t h a t all my films are excellent, b u t one can do it with fair consistency, and I think it is worth considering. T h o m a s T. W h i t e (Seattle, WA): I certainly agree with Drs. Tompkins and Doane t h a t proper roentgenography, choledochoscopy and even pressure measurements may be useful in preventing recurrence. I think, however, t h a t if all the roentgenographs are as opaque as Dr. Doane's, you probably could not see any stones at all. Second, some workers do choledochoscopy intraoperatively without obtaining a completion cholangiogram. The roentgenograph taken several days later shows a residual stone. The authors are quite clear in pointing out t h a t there is a high failure rate after reexploration tbr recurrent or residual stones and t h a t endoscopic sphincterotomy might offer less morbidity and mortality than reoperation. Follow-up is required before we know whether or not these patients are going to have recurrence. I would like to know how long a n e n d o s c 0 p i c cut was made in the sphincter. W h e n we started, in the late 1940s at Bellevue Hospital, we made 8 m m sphincterotomies and they obstructed. I would like to reemphasize t h a t not everyone is as skillful as Dr. Shapiro. W h e n I talked to Professor Fric, head of gastroenterology at Prague, he said t h a t after a Czech endoscopist has done 600 endoscopic retrograde cholangiopancreatographies, then he may try sphincterotomy. I know Dr. Shapiro has done at least t h a t number; maybe we should defer to colleagues like him when we have this type of procedure done. H i r a m H. B e l d i n g I I I (Riverside, CA): I would like to emphasize the statements about how important initial exploration of the common duct is rather than relying too much on cholangiography. It was my privilege to be trained for 1 year by Dr. Waltman Walters, who ritualistically showed how to explore the common duct, and the way the common duct was explored by him was over and over and over again. The incision was made in the common duct. It was first flushed out very carefully. Scoops were used. I t was flushed. Scoops were used, before the sphincter was ever dilated, and it was always amazing to me that one more time brought that little stone out of the ampulla. At t h a t time, we were not using cholangiography, and I think we had about the same accuracy. All of us are familiar with the air bubble we get from the cholangiogram, which is disconcerting. We have seen, I believe, as many errors with cholangiography as with careful exploration. H o w a r d S h a p i r o (San Francisco, CA): This is strange territory for an internist to invade, but I wanted to be here particularly to get some feedback on this study, and I am delighted to see t h a t no one was terribly vehement about defending his territory, namely the surgical t r e a t m e n t of retained or recurrent common duct stones. I think t h a t Dr. Allen gave a very nice discussion of the material we have all worked on together, but I do want to respond briefly to Dr. T o m p k i n s ' s theory about the costeffectiveness of endoscopic sphincterotomy versus secondary Choledochotomy with or without a drainage procedure.
Volume 142, July 1981
Our patients generally are brought into the hospital when we do endoscopic sphincterotomy. On the first hospital day they get diagnostic retrograde cholangiography and at the same sitting t h a t endoscopic sphincterotomy and stone extraction take place. The patients are generally observed for 48 hours thereafter and then sent home with unlimited activities and no convalescent time whatsoever. That is a 3 day hospital stay for endoscopic sphincterotomy and stone extraction. I think this compares favorably with the time t h a t is taken to do secondary choledoehotomy. L a w r e n c e W. W a y (closing): We did not plan in this study to address the question Of retained stones, although it is impossible to separate completely t h a t issue from the one at hand. In this report we concentrated on the patient who is discovered to have additional disease late after the initial biliary operation. Nevertheless, comments in regard to prevention are pertinent. Prevention requires a multifaceted diagnostic approach at the time of the original choledochotomy. Precision in performing common duct exploration, choledochoscopy and completion cholangiography are the principal means of avoiding retained stones. All the evidence to date suggests t h a t the three techniques supplement each other, and no one of them can be relied upon alone for optimal results. However, the main objectives of this study were (1) to determine when to perform a drainage procedure when operating on a patient with postcholecystectomy cho]edocholithiasis, and (2) to assess endoscopic sphincterotomy as an alternative to surgery. Our data led us to conclude that previous analyses of the indications for a drainage procedure were polarized; some surgeons would use a drainage procedure in a majority of patients, while others would do so rarely. Our experience demonstrates it is possible to identify specific patients who are at high risk for recurrent disease if a drainage procedure is not performed, and t h a t it is unnecessary to perform a drainage procedure in the remainder (the majority). However, endoscopic sphincterotomy has b e e n so successful t h a t we now consider it preferable to laparotomy in most patients with recurrent and residual stones. Initially, there were questions of efficacy and safety. But the complication rate has been acceptable, and the procedure has freed the duct of stones in a high percentage of cases. We agree with Dr. White that the judgment is not final; more time must pass before the risks of recurrent stones and late restenosis are known. So far, however, it appears that the sphincterotomy remains patent, although we have not systematically studied this point. For example, there has been no instance of late recurrent cholangitis, and in the few patients given barium many months after sphincterotomy, it refluxed into the bile ducts. From the standpoint of direct (hospital and physician) and indirect (from time off work) costs, sphincterotomy has a clear-cut advantage over surgery. It is i m p o r t a n t to emphasize Dr. White's point t h a t endoscopists are incapable of performing endoscopic sphincterotomy with the requisite safety and success without special training. Dr. Shapiro, for example, spent 3 months studying this technique at another institution before performing his first procedure in San Francisco. Good success and low complication rates can be expected only when this approach is followed.
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