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Management of choledocholithiasis in the time of laparoscopic cholecystectomy
Management of Choledocholithiasis in the Time of Laparoscopic Cholecystectomy John W. Lorimer,
MD, FRCSC, FACS, Jean Lauzon, MD, Robert J. Fairfull-Smith, Jean-Denis Yelle, MD, FRCSC, Ottawa, Ontario
BACKGROUND: The best way to detect and manage common duct stones in conjunction with laparoscopic cholecystectomy is not agreed upon at the present time. PATIENTS AND METHODS: Our experience with choledocholithiasis in a consecutive series of 1,I 23 cholecystectomies (94% by laparoscopy) has been reviewed. Suspected duct stones were investigated preoperatively or postoperatively by endoscopic retrograde cholangiography (ERC), and if necessary, duct clearance was attempted by endoscopic sphincterotomy (ES). No attempt was made to identify choledocholithiasis intraoperatively. RESULTS: Endoscopic retrograde cholangiography was performed in 11% of patients, and 32% of these required ES. The complication rate of ERC and ES was 8%, without mortality. Two patients required a second operation for missed choledocholithiasis, for a reoperation rate of 0.2%. CONCLUSION: We believe that primary or secondary open surgery is only occasionally necessary for the management of choledocholithiasis. Preoperative ERC and ES for suspected duct stones, with the same strategy employed as a salvage for stones presenting after cholecystectomy, was safe and efficient. Am J Surg. 1997;174:68-71. 0 1997 by Excerpta Medica, Inc.
B
efore the widespread adoption of intraoperative cholangiography (IOC), choledocholithiasis could be suspected preoperatively only on clinical grounds, and the available therapy was common bile duct exploration (CBDE). Bartlett and Waddell’ defined preoperative criteria (jaundice, history of jaundice or pancreatitis) and intraoperative criteria (palpable duct stones, dilatation of the cystic or common ducts) for the performance of CBDE, but they were concerned that the addition of choledochotomy tripled the mortality over cholecystectomy alone. Reported rates of CBDE were 29% to 42%, with positive findings in only 28% to 38% of explorations. With the introduction of IOC, exploration rates fell to 25% to 29%, From the Department of Surgery, University of Ottawa, Ottawa, Ontario, Canada. Requests for reprints should be addressed to J. W. Lorimer, MD, Department of Surgery, Ottawa General Hospital, 501 Smyth Road, Room K-l 1, Ottawa, Ontario, Kl H 8L6, Canada. Manuscript submitted March 11, 1996 and accepted in revised form September 26, 1996.
71 68
e 1997 by Excerpta All rights reserved.
Medica,
Inc.
MB, ChB, FRCSC,
and positive explorations rose to 62% to 66%. Intraoperative cholangiography itself is free of complications, but White and Hart’ drew attention to common duct injuries from explorations of small ducts after false-positive IOCs. A 1% to 4% incidence of secondary reoperations for missed choledocholithiasis persisted even with IOC.3,4 The introduction of stone removal through the T-tube tract and of endoscopic sphincterotomy (ES) provided alternatives to reoperation, and the reported success rates were 86% to 95%.ja6 After the introduction of laparoscopic cholecystectomy (LC), the “world turned upside-down” as it related to the detection and management of choledocholithiasis, but no clear consensus has emerged as to the best current therapy. Routine preoperative ERC has been described, but not recommended7; selective ERC with ES, if indicated, has more often been advocated. s,’ Because of concerns about the late effects of ES, open CBDE has been advised in younger patients. lo Reported rates for IOC have varied from less than 5 0/o8,11.12 to routine,“,l4 and for stones detected this way, management options have included laparoscopic CBDE,‘3,‘5.‘6 conversion and open CBDET,‘0,16 and later ES 17.18Unsuspected duct stones have been found by routine IOC in 4% to 6 ‘0/ , 13.” but reoperation rates after selective IOC have been only 0% to 0.4%,2e-22 so many stones must pass spontaneously or remain asymptomatic. For patients presenting postoperatively with symptomatic duct stones, ES has been the preferred treatment.23,24 Before we began to perform LC, we had used IOC selectively, and our experience with ES for residual and recurrent stones had been favorable; we believed that selective preoperative ERC/ES most closely resembled our previous practice, although we expected to treat some symptomatic duct stones postoperatively. Because we did not intend to perform open CBDE, we stopped doing IOC. In fact, our major concern related to possible duct injuries14xz5; we now believe (Table I) that the performance of IOC bears little or no relationship to the occurrence of duct injuries during LC. The present report outlines our experience with selective preoperative and postoperative ERC/ES for the detection and management of symptomatic choledocholithiasis during the era of LC. More particularly, we wish to review and document our results with suspected and proven duct stones presenting after LC.
PATIENTS
AND
METHODS
Since 1991 a data-base has been maintained prospectively at our university hospital on all cholecystectomies, and the present series (n = 1,123) represents consecutive cholecystectomies performed by all surgeons performing LC; it ineludes LCs (n = 1,000) and converted procedures (n = 57) as well as open cholecystectomies (n = 66). These last cases 0002-961 O/97/$1 PII SOOO2-9610(97)00027-5
7.00
1 MANAGEMENT TABLE
I Complications Cholecystectomy
in 66 Patients with or Conversion
Laparoscopic (n = 1,057)
Proven missed choledocholithiasis (2 reoperations) Suspected missed choledocholithiasis Wound infection Late port-site hernia Atelectasis/pneumonia/respiratory failure* Bile leaks (1 reoperation) Urinary retention Conversion for intraoperative hemorrhage Postoperative hemorrhage (1 reoperation) Prolonged ileus (no reoperations) Myocardial infarction Minor bowel/liver injuries (no reoperations) Common bile duct tear Subhepatic hematoma Late abortion Deep vein thrombosis Clostridium difficile colitis Mesenteric ischemia* Total
12 11 8 7 6 6 4 3 2 2 2 2 1 1 1 1 1 1 71
* One was fata/.
OF
CHOLEDOCHOLITHIASIS/LORlMER
ET AL 1
tectomy; and in 3, IOC was negative. In 8 postoperative failures, 2 required early reoperation and the others remain asymptomatic. Eighteen open IOCs were done, for a rate of 15%; 11 laparoscopic IOCs were attempted and 8 were successful, for a rate of 1%. Eleven CBDEs were performed altogether, and in 6, duct clearance was accomplished; in 5, eventual clearance required ES or T-tube tract extraction. No Iaparoscopic CBDEs were attempted. Altogether 46 patients were proven by ERC or IOC to have duct stones, for a rate of 4%. We believe that spontaneous migration of gallstones through the common duct occurred in 118 more patients, because of pancreatitis/hyperamylasemia (75), pain with transient jaundice or abnormal liver function tests (34), and pain with ultrasound abnormalities (9). Combined, the rate of suspected and proven choledocholithiasis was therefore 15%. Only 2 patients underwent a second operation for choledocholithiasis, for a rate of 0.2%. Our average costs for endoscopic procedures in US dollars was $600, and for IOC it was $130 (it must be noted that this represents all identified costs of the procedures including physicians’ fees, but is not strictly comparable with other reports” that detail charges billed to providers).
COMMENTS were included with the knowledge that in some the choice was elected because of known or suspected choledocholithiasis. The patients’ ages ranged from 5 to 100 years, and the male-to-female ratio was 1 to 3.6. Cholelithiasis was present in 99%. The indications for surgery included chronic biliary pain (73%), acute cholecystitis (17%), gallstone pancreatitis (8%) and jaundice/cholangitis (5%). For LCs, the median operating time was 74 minutes.
RESULTS There were 2 deaths (both patients older than 70 years) for a mortality rate of 0.2%; operative morbidity rate for LCs and converted procedures was 6% (Table I). The single duct injury was a traction tear at the cystic-common duct junction, and was laterally repaired without conversion. Eleven patients were suspected (but not proven) to have passed stones postoperatively on the basis of biliary pain/ biochemical abnormalities (6) and mild pancreatitis (5). Twelve more cases were proven with pain/biochemical abnormalities/jaundice (7) and pancreatitis, pain/stone on ultrasound, incidental autopsy finding, bile leak, abnormal Ttube cholangiogram ( 1 each). The decision to perform open cholecystectomy was made on the basis of suspected choledocholithiasis in 6 patients (most in 1991). In 4 more, an open procedure was elected because of failure to either visualize or clear the CBD by ERC/ES. Eighty-six patients underwent preoperative ERC and 27 underwent ES (Table II). Thirty-nine ERC’s were attempted postoperatively and 10 ES’s were performed (Table III). So altogether, 123 patients (11%) underwent 136 ERC attempts (2 patients were studied before and after operation) and 37 underwent ES; the combined failure rate of ERC and ES was 11%. In 111, the ERC was performed to evaluate suspected choledocholithiasis, and in the remaining 12 the study was done for other indications. The ERC/ES morbidity was 8%, and there were no deaths (Table IV). Because of preoperative failures of ERC/ES, 4 patients underwent open cholecysTHE
In patients with cholelithiasis, choledocholithiasis is associated in 8% to 15%.““” Reported detection rates with LC have been 4% to 12%‘-9~‘2,‘i~‘6,‘6,‘8 and the higher rates have been from series that used routine IOC. Attempts to identify choledocholithiasis by the application of preoperative clinical, biochemical, and ultrasound criteria have shown excellent negative predictive ability.Z”m32 Patients not exhibiting any of these indicators preoperatively have been shown to be free of duct calculi in 92% to 99% of Positive predictive ability has been less satisfaccases.27,29*3@ tory, and patients categorized as at-risk have been proven to have choledocholithiasis in 13% to 58% of cases.2H,29,‘i~32 The timing of such assessments of the common duct in relationship to cholangiography and cholecystectomy has not been well studied.‘“,” Sometimes no distinction has been made between current and recent jaundice,‘2,33 or between recent and persisting biochemical abnormalities.‘? Definition of ultrasonographic common duct dilatation has also been inconstant, with measurements of 6 mm to 12 mm being used as predictive indicators.‘“,‘“,“‘14 If the interval between duct assessment and ERC has been long, passage of stones through the sphincter of Oddi may result in an excessive number of normal studies,3”x3’ and 1 to 10 days has been suggested as a reasonable time lapse.3@ This interval would be almost utopian, given the exigencies Spontaneous gallstone migration of clinical practice. through the sphincter has been recognized for many years and has been best studied in relationship to biliary pancreatitis.35 Before LC, when liberal use of selective IOC led to simultaneous operative treatment of detected choledocholithiasis, gallstone migration had less clinical significance than it assumes at the present time. This is particularly true for those surgeons who attempt to identify and treat choledocholithiasis before LC by ERC/ES, and failure to distinguish between gallstone migration and persisting choledocholithiasis will result in nontherapeutic ERCs from the former patient group. When treatment of duct stones identified by laparoscopic IOC was deferred for postoperative
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TABLE II Indications
and
Results
of Preoperative Endoscopic in 86 Patients
Retrograde
Indications
Cholangiography Positive
Jaundice/hyperbilirubinemia History of jaundice History of pancreatitis Isolated enzyme abnormalities Bile duct dilatation over 9 mm/common ultrasound Unsuccessful studies (5) Diagnostic study (1) Total positive results
Results 16/18 O/l 0 1126 l/11
bile duct stone
on 9/15 NA NA 27180
NA = not applicable.
TABLE III Indications
for Postoperative Cholangiography
Endoscopic in 39 Patients
Indication
Retrograde Number
Post-cholecystectomy syndrome Jaundice Mild pancreatitis Biliaty colic/enzyme abnormalities Bile leak from drain Failed common bile duct exploration Enzyme abnormalities/stone on ultrasound Pain/stone on ultrasound Total
11 9 6 4 4 3 1 1 39
TABLE IV Complications of Endoscopic Retrograde Cholangiography and Endoscopic Sphincterotomy in 123 Patients Complication
Number
Pancreatitis (no operations) Unexplained pneumoperitoneum Duodenal perforation (operation) Total
8 1 1 10
(operation)
ERC/ES, spontaneous passage was found to have taken place in over half.18,36 With duct stones less than 6 to 8 mm, observation with the expectation of eventual uneventful migration has been suggested as a reasonable therapeutic option.r7x3’ If reliance is placed on ERC/ES to manage choledocholithiasis, it has been suggested that 10% of patients will require studies preoperatively or postoperatively, and that expert endoscopists will perform fewer preoperative studies with the knowledge that it will nearly always be possible to clear the common duct postoperatively if required.3i The rate of performance of ERC/ES in conjunction with LC has been 8% to 92%, with preoperative identification of duct calculi in 11% to 53% of cases.779’12Our rate of 11% represents about the average, but we have been disappointed that duct calculi were identified in only 35%. In our series, in 91% of duct stones proven preoperatively there was either jaundice/hyperbilirubinemia persisting at the time of ERC, or there was ultrasonographic evidence of duct dilatation or stones. We now believe that those with resolving 70
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biochemical abnormalities and normal ultrasound studies should not undergo ERC, and we think that this can increase our rate of positive studies. We proved choledocholithiasis in 4%, but we suspected duct stones in 11% more. Some of these latter cases may represent incorrect provisional diagnoses, but we believe that many likely represent instances of gallstone migration. Failure to accomplish duct clearance by ERC/ES preoperatively or postoperatively is a clear concern for surgeons who rely on this strategy. We have failed to visualize the common bile duct or to complete an intended ES in 1 l%, but despite this have managed a low reoperation rate of 0.2%. A second attempt at ERC/ES (with or without preliminary insertion of a facilitating transhepatic, transpapillary guidewire) should be carried out before resorting to open CBDE.‘z Evaluation must clearly identify deaths, serious complications of ERC/ES, second operations for duct stones, and serious complications from missed choledocholithiasis. The alternatives to selective ERC/ES for the management of choledocholithiasis are open and laparoscopic CBDE. The use of open CBDE results in the loss of other advantages of minimally invasive surgery, and is less attractive to most patients.36,37 Excellent results have been reported for laparoscopic CBDE, both by the transcystic approachi3j’j and by choledochotomy.‘” It has been thought that with increasing expertise in laparoscopic surgery, the use of these techniques will become widespread,ii but in fact there are large geographic areas like our own where laparoscopic CBDE is not presently practiced. These procedures are clearly more difficult than simple LC,‘6,‘h but many surgeons who have not adopted laparoscopic CBDE have meanwhile progressed to other technically demanding laparoscopic procedures. In expert hands, the operating times reported to perform _ ^ laparoscopic CBDE have ranged from 1.5 to 3.5 hours.“-’ ’ Proponents of laparoscopic CBDE have raised concerns about early morbidity and long-term effects of ERC/ ES. L3~1i,‘6~‘6Our early morbidity of 8% is comparable with other reports of 5% to 10%.“,L7.3S The only long-term sequelae documented have been late papillary stenosis and cholangitis in 6% to 13%, with follow-up of 2 to 11 years, “x4 and most have been successfully treated by repeat ES. Nevertheless, it seems prudent to minimize the number of procedures performed, and we have only used ERC/ES JULY
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MANAGEMENT
for the investigation and management of duct stones in symptomatic patients. In conclusion, we believe that the selective use of ERC/ ES with LC is a strategy that competes favorably with laparoscopic CBDE for the management of choledocholithiasis. Primary open surgery for duct calculi has only occasion ally been necessary. Our morbidity has been 8% with no deaths. Our overall incidence of missed choledocholithiasis has been 2%, and secondary reoperations have been required in only 0.2%. We believe that our indications for preoperative ERC can be further refined by paying more attention to distinguishing between gallstone migration and persisting choledocholithiasis.
REFERENCES 1. Bartlett MK, Waddell WR. Indications for common-duct exploration. NEJM. 1958;258:164-167. 2. White TT, Hart M]. Cholangiography and small duct injury. Am J Surg. 1985;149:640-643. 3. Girard RM, Legros G. Retained and recurrent bile duct stones. Ann Surg. 1981;193:150-154. 4. Hall RC, Saklyalak P, Kim SK, et al. Failure of operative cholangiography to prevent retained common duct stones. Am J Surg. 1973;125:51-63. 5. Allen B, Shapiro H, Way LW. Management of recurrent and residual common duct stones. Am J Surg. 1981;142:41-47. 6. Burhenne HJ. Percutaneous extraction of retained biliary tract stones: 661 patients. Am J Roentgenol. 1980;134:888-898. 7. Neuhaus H, Feussner H, Ongeheuer A, et al. Prospective evaluation of the use of endoscopic retrograde cholangiography prior to laparoscopic cholecystectomy. Endoscopy. 1992;24:745-749. 8. Lillemoe KD, Yeo CJ, Talamini MA, et al. Selective cholangiography: current role in laparoscopic cholecystectomy. Ann Surg. 1992;215:669-676. 9. Miller RE, Kimmelstiel FM, Winkler WP. Management of common bile duct stones in the era of laparoscopic cholecystectomy. Am.l Surg. 1995;169:273-276. 10. Phillips EH. Controversies in the management of common duct calculi. Surg Clin North Am. 1994;74:93 l-95 1. 11. Perissat J, Collet D, Belliard R, et al. Laparoscopic cholecystectomy: the state of the art (a report on 700 consecutive cases). World ./ Surg. 1992;16:1074-1082. 12. Barkun JS, Fried GM, Barkun AN, et al. Cholecystectomy without operative cholangiography: implications for common bile duct injury and retained common bile duct stones. Ann Surg. 1993;218:371-379. 13. Phillips EH, Carroll BJ, Pearlstein AR, et al. Laparoscopic choledochoscopy and extraction of common bile duct stones. World J Surg. 1993;17:22-28. 14. Sackier JM, Berci G, Phillips E, et al. The role of cholangiography in laparoscopic cholecystectomy. Arch Surg. 1991;126:10211026. 15. Petelin JB. Laparoscopic approach to common duct pathology. Am J Surg. 1993;165:487-491. 16. Stoker ME. Common bile duct exploration in the era of laparoscopic surgery. Arch Surg. 1995;130:265-269. 17. Perissat J, Huibregtse K, Keane FBV, et al. Management of bile duct stones in the era of laparoscopic cholecystectomy. Br J Surg. 1994;81:799-810. 18. Hainsworth PJ, Rhodes M, Gompertz RHK, et al. Imaging of the common bile duct in patients undergoing laparoscopic cholecystectomy. Gut. 1994;35:991-995.
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ET AL
19. Pernthaler H, Sandbichler P, Schmid T, Margreiter R. Cperative cholangiogmphy in elective cholccystectomy. Br J Surg. 1990;77:399-400. 20. Ganey JB, Johnson PA Jr, Prillaman I’E, McSwain GR. Cholecystectomy: clmical experience with a large series. Am J Surg. 1986;151:352-357. 21. Gerber A, Apt MK. The case against routine operative cholangiography. AmJ Surg. 1982;143:734-736. 22. Gregg RO. The case for selective cholangiography. Am J Surg. 1988;155:540-544. 23. Miller BM, Kozarek RA, Ryan JA Jr, et al. Surgical versus endoscopic management of common bile duct stones. Ann Surg. 1988;207:135-141. 24. Schmitt CM, Baillie J, Cotton PB. ERCP following laparoscopic cholecystectomy: a safe and effective way to manage CBD stones and complications. HPB Surg. 1995;8:187-192. 25. Lorimer JW, Fairfull-Smith RJ. Intraoperative cholangiography is not essential to avoid duct injuries during laparoscopic cholecystectomy. Am J Surg. 1995;169:344-347. 26. Phillips EH, Liberman M, Carroll BJ, et al. Bile duct stones in the laparoscopic era: is preoperative sphincterotomy necessary? Arch Surg. 1995;130:880-886. 27. Cotton PB, Chung SC, Davis WZ, et al. Issues in cholecystectomy and management of duct stones. Am] Gastroenterol. 1994;89(8 Suppl):S169-176. 28. Jones DB, Dunnegan DL, Soper NJ. Results of a change to routine fluorocholangiography during laparoscopic cholecystectomy. Surgery. 1995;118:693-702. 29. Houdart R, Perniceni T, Dame B, et al. Predicting common bile duct lithiasis: determination and prospective validation of a model predicting low risk. Am J Surg. 1995;170:38-43. 30. Barkun AN, Barkun JS, Fried GM, et al. Useful predictors of bile duct stones in patients undergoing laparoscopic cholecystectomy. Ann Surg. 1994;220:32-39. 3 1. Welbourn CRB, Haworth JM, Leaper DJ, Thompson MH. Prospective evaluation of ultrasonography and liver function tests for preoperative assessment of the bile duct. Br J Surg. 1995;82:13711373. 32. Hauer-Jensen M, Karesen R, Nygaard K, et al. Predictive ability of choledocholithiasis indicators: a prospective evaluation. Ann Surg. 1985;202:64+68. 33. Cotton PB. Endoscopic retrograde cholangiopancreatography and laparoscopic cholecystectomy. Am ] Surg. 1993;165:474-478. 34. IMontariol T, Rey C, Chat-her A, et al. Preoperative evaluation of the probability of common bile duct stones. J Am Coil Surg. 1995;180:293-296. 35. Acosta JM, Ledesma CL. Gallstone migration as a cause of acute pancreatitis. NEJM. 1974;290:484-487. 36. Fitzgibbons RJ Jr, Ryberg AA, Ulualp KM, et al. An alternative technique for treatment of choledocholithiasis found at laparoscopic cholecystectomy. Arch Surg. 1995;130:638-642. 37. Cotton PB. Endoscopic management of bile duct stones (apples and oranges). Gut. 1984;25:587-597. 38. Sherman S, Ruffolo TA, Hawes RH, Lehman GA. Complications of endoscopic sphincterotomy: a prospective series with emphasis on the increased risk associated with sphincter of Oddi dysfunction and non-dilated bile ducts. Gastroenterology. 1991;101:1068-1075. 39. Hawes RH, Cotton PB, Vallon AG. Follow-up 6-l 1 years after duodenoscopic sphincterotomy for stones in patients with prior cholecystectomy. Gastroenterology. 1990;98:1008-1012. 40. Kullman E, Borch K, Liedberg G. Long-term follow-up after endoscopic management of retained and recurrent common duct stones, Acta Chir SC&. 1989;155:395-399.
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MD, FRCSC, FACS, Jean Lauzon, MD, Robert J. Fairfull-Smith, Jean-Denis Yelle, MD, FRCSC, Ottawa, Ontario
BACKGROUND: The best way to detect and manage common duct stones in conjunction with laparoscopic cholecystectomy is not agreed upon at the present time. PATIENTS AND METHODS: Our experience with choledocholithiasis in a consecutive series of 1,I 23 cholecystectomies (94% by laparoscopy) has been reviewed. Suspected duct stones were investigated preoperatively or postoperatively by endoscopic retrograde cholangiography (ERC), and if necessary, duct clearance was attempted by endoscopic sphincterotomy (ES). No attempt was made to identify choledocholithiasis intraoperatively. RESULTS: Endoscopic retrograde cholangiography was performed in 11% of patients, and 32% of these required ES. The complication rate of ERC and ES was 8%, without mortality. Two patients required a second operation for missed choledocholithiasis, for a reoperation rate of 0.2%. CONCLUSION: We believe that primary or secondary open surgery is only occasionally necessary for the management of choledocholithiasis. Preoperative ERC and ES for suspected duct stones, with the same strategy employed as a salvage for stones presenting after cholecystectomy, was safe and efficient. Am J Surg. 1997;174:68-71. 0 1997 by Excerpta Medica, Inc.
B
efore the widespread adoption of intraoperative cholangiography (IOC), choledocholithiasis could be suspected preoperatively only on clinical grounds, and the available therapy was common bile duct exploration (CBDE). Bartlett and Waddell’ defined preoperative criteria (jaundice, history of jaundice or pancreatitis) and intraoperative criteria (palpable duct stones, dilatation of the cystic or common ducts) for the performance of CBDE, but they were concerned that the addition of choledochotomy tripled the mortality over cholecystectomy alone. Reported rates of CBDE were 29% to 42%, with positive findings in only 28% to 38% of explorations. With the introduction of IOC, exploration rates fell to 25% to 29%, From the Department of Surgery, University of Ottawa, Ottawa, Ontario, Canada. Requests for reprints should be addressed to J. W. Lorimer, MD, Department of Surgery, Ottawa General Hospital, 501 Smyth Road, Room K-l 1, Ottawa, Ontario, Kl H 8L6, Canada. Manuscript submitted March 11, 1996 and accepted in revised form September 26, 1996.
71 68
e 1997 by Excerpta All rights reserved.
Medica,
Inc.
MB, ChB, FRCSC,
and positive explorations rose to 62% to 66%. Intraoperative cholangiography itself is free of complications, but White and Hart’ drew attention to common duct injuries from explorations of small ducts after false-positive IOCs. A 1% to 4% incidence of secondary reoperations for missed choledocholithiasis persisted even with IOC.3,4 The introduction of stone removal through the T-tube tract and of endoscopic sphincterotomy (ES) provided alternatives to reoperation, and the reported success rates were 86% to 95%.ja6 After the introduction of laparoscopic cholecystectomy (LC), the “world turned upside-down” as it related to the detection and management of choledocholithiasis, but no clear consensus has emerged as to the best current therapy. Routine preoperative ERC has been described, but not recommended7; selective ERC with ES, if indicated, has more often been advocated. s,’ Because of concerns about the late effects of ES, open CBDE has been advised in younger patients. lo Reported rates for IOC have varied from less than 5 0/o8,11.12 to routine,“,l4 and for stones detected this way, management options have included laparoscopic CBDE,‘3,‘5.‘6 conversion and open CBDET,‘0,16 and later ES 17.18Unsuspected duct stones have been found by routine IOC in 4% to 6 ‘0/ , 13.” but reoperation rates after selective IOC have been only 0% to 0.4%,2e-22 so many stones must pass spontaneously or remain asymptomatic. For patients presenting postoperatively with symptomatic duct stones, ES has been the preferred treatment.23,24 Before we began to perform LC, we had used IOC selectively, and our experience with ES for residual and recurrent stones had been favorable; we believed that selective preoperative ERC/ES most closely resembled our previous practice, although we expected to treat some symptomatic duct stones postoperatively. Because we did not intend to perform open CBDE, we stopped doing IOC. In fact, our major concern related to possible duct injuries14xz5; we now believe (Table I) that the performance of IOC bears little or no relationship to the occurrence of duct injuries during LC. The present report outlines our experience with selective preoperative and postoperative ERC/ES for the detection and management of symptomatic choledocholithiasis during the era of LC. More particularly, we wish to review and document our results with suspected and proven duct stones presenting after LC.
PATIENTS
AND
METHODS
Since 1991 a data-base has been maintained prospectively at our university hospital on all cholecystectomies, and the present series (n = 1,123) represents consecutive cholecystectomies performed by all surgeons performing LC; it ineludes LCs (n = 1,000) and converted procedures (n = 57) as well as open cholecystectomies (n = 66). These last cases 0002-961 O/97/$1 PII SOOO2-9610(97)00027-5
7.00
1 MANAGEMENT TABLE
I Complications Cholecystectomy
in 66 Patients with or Conversion
Laparoscopic (n = 1,057)
Proven missed choledocholithiasis (2 reoperations) Suspected missed choledocholithiasis Wound infection Late port-site hernia Atelectasis/pneumonia/respiratory failure* Bile leaks (1 reoperation) Urinary retention Conversion for intraoperative hemorrhage Postoperative hemorrhage (1 reoperation) Prolonged ileus (no reoperations) Myocardial infarction Minor bowel/liver injuries (no reoperations) Common bile duct tear Subhepatic hematoma Late abortion Deep vein thrombosis Clostridium difficile colitis Mesenteric ischemia* Total
12 11 8 7 6 6 4 3 2 2 2 2 1 1 1 1 1 1 71
* One was fata/.
OF
CHOLEDOCHOLITHIASIS/LORlMER
ET AL 1
tectomy; and in 3, IOC was negative. In 8 postoperative failures, 2 required early reoperation and the others remain asymptomatic. Eighteen open IOCs were done, for a rate of 15%; 11 laparoscopic IOCs were attempted and 8 were successful, for a rate of 1%. Eleven CBDEs were performed altogether, and in 6, duct clearance was accomplished; in 5, eventual clearance required ES or T-tube tract extraction. No Iaparoscopic CBDEs were attempted. Altogether 46 patients were proven by ERC or IOC to have duct stones, for a rate of 4%. We believe that spontaneous migration of gallstones through the common duct occurred in 118 more patients, because of pancreatitis/hyperamylasemia (75), pain with transient jaundice or abnormal liver function tests (34), and pain with ultrasound abnormalities (9). Combined, the rate of suspected and proven choledocholithiasis was therefore 15%. Only 2 patients underwent a second operation for choledocholithiasis, for a rate of 0.2%. Our average costs for endoscopic procedures in US dollars was $600, and for IOC it was $130 (it must be noted that this represents all identified costs of the procedures including physicians’ fees, but is not strictly comparable with other reports” that detail charges billed to providers).
COMMENTS were included with the knowledge that in some the choice was elected because of known or suspected choledocholithiasis. The patients’ ages ranged from 5 to 100 years, and the male-to-female ratio was 1 to 3.6. Cholelithiasis was present in 99%. The indications for surgery included chronic biliary pain (73%), acute cholecystitis (17%), gallstone pancreatitis (8%) and jaundice/cholangitis (5%). For LCs, the median operating time was 74 minutes.
RESULTS There were 2 deaths (both patients older than 70 years) for a mortality rate of 0.2%; operative morbidity rate for LCs and converted procedures was 6% (Table I). The single duct injury was a traction tear at the cystic-common duct junction, and was laterally repaired without conversion. Eleven patients were suspected (but not proven) to have passed stones postoperatively on the basis of biliary pain/ biochemical abnormalities (6) and mild pancreatitis (5). Twelve more cases were proven with pain/biochemical abnormalities/jaundice (7) and pancreatitis, pain/stone on ultrasound, incidental autopsy finding, bile leak, abnormal Ttube cholangiogram ( 1 each). The decision to perform open cholecystectomy was made on the basis of suspected choledocholithiasis in 6 patients (most in 1991). In 4 more, an open procedure was elected because of failure to either visualize or clear the CBD by ERC/ES. Eighty-six patients underwent preoperative ERC and 27 underwent ES (Table II). Thirty-nine ERC’s were attempted postoperatively and 10 ES’s were performed (Table III). So altogether, 123 patients (11%) underwent 136 ERC attempts (2 patients were studied before and after operation) and 37 underwent ES; the combined failure rate of ERC and ES was 11%. In 111, the ERC was performed to evaluate suspected choledocholithiasis, and in the remaining 12 the study was done for other indications. The ERC/ES morbidity was 8%, and there were no deaths (Table IV). Because of preoperative failures of ERC/ES, 4 patients underwent open cholecysTHE
In patients with cholelithiasis, choledocholithiasis is associated in 8% to 15%.““” Reported detection rates with LC have been 4% to 12%‘-9~‘2,‘i~‘6,‘6,‘8 and the higher rates have been from series that used routine IOC. Attempts to identify choledocholithiasis by the application of preoperative clinical, biochemical, and ultrasound criteria have shown excellent negative predictive ability.Z”m32 Patients not exhibiting any of these indicators preoperatively have been shown to be free of duct calculi in 92% to 99% of Positive predictive ability has been less satisfaccases.27,29*3@ tory, and patients categorized as at-risk have been proven to have choledocholithiasis in 13% to 58% of cases.2H,29,‘i~32 The timing of such assessments of the common duct in relationship to cholangiography and cholecystectomy has not been well studied.‘“,” Sometimes no distinction has been made between current and recent jaundice,‘2,33 or between recent and persisting biochemical abnormalities.‘? Definition of ultrasonographic common duct dilatation has also been inconstant, with measurements of 6 mm to 12 mm being used as predictive indicators.‘“,‘“,“‘14 If the interval between duct assessment and ERC has been long, passage of stones through the sphincter of Oddi may result in an excessive number of normal studies,3”x3’ and 1 to 10 days has been suggested as a reasonable time lapse.3@ This interval would be almost utopian, given the exigencies Spontaneous gallstone migration of clinical practice. through the sphincter has been recognized for many years and has been best studied in relationship to biliary pancreatitis.35 Before LC, when liberal use of selective IOC led to simultaneous operative treatment of detected choledocholithiasis, gallstone migration had less clinical significance than it assumes at the present time. This is particularly true for those surgeons who attempt to identify and treat choledocholithiasis before LC by ERC/ES, and failure to distinguish between gallstone migration and persisting choledocholithiasis will result in nontherapeutic ERCs from the former patient group. When treatment of duct stones identified by laparoscopic IOC was deferred for postoperative
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TABLE II Indications
and
Results
of Preoperative Endoscopic in 86 Patients
Retrograde
Indications
Cholangiography Positive
Jaundice/hyperbilirubinemia History of jaundice History of pancreatitis Isolated enzyme abnormalities Bile duct dilatation over 9 mm/common ultrasound Unsuccessful studies (5) Diagnostic study (1) Total positive results
Results 16/18 O/l 0 1126 l/11
bile duct stone
on 9/15 NA NA 27180
NA = not applicable.
TABLE III Indications
for Postoperative Cholangiography
Endoscopic in 39 Patients
Indication
Retrograde Number
Post-cholecystectomy syndrome Jaundice Mild pancreatitis Biliaty colic/enzyme abnormalities Bile leak from drain Failed common bile duct exploration Enzyme abnormalities/stone on ultrasound Pain/stone on ultrasound Total
11 9 6 4 4 3 1 1 39
TABLE IV Complications of Endoscopic Retrograde Cholangiography and Endoscopic Sphincterotomy in 123 Patients Complication
Number
Pancreatitis (no operations) Unexplained pneumoperitoneum Duodenal perforation (operation) Total
8 1 1 10
(operation)
ERC/ES, spontaneous passage was found to have taken place in over half.18,36 With duct stones less than 6 to 8 mm, observation with the expectation of eventual uneventful migration has been suggested as a reasonable therapeutic option.r7x3’ If reliance is placed on ERC/ES to manage choledocholithiasis, it has been suggested that 10% of patients will require studies preoperatively or postoperatively, and that expert endoscopists will perform fewer preoperative studies with the knowledge that it will nearly always be possible to clear the common duct postoperatively if required.3i The rate of performance of ERC/ES in conjunction with LC has been 8% to 92%, with preoperative identification of duct calculi in 11% to 53% of cases.779’12Our rate of 11% represents about the average, but we have been disappointed that duct calculi were identified in only 35%. In our series, in 91% of duct stones proven preoperatively there was either jaundice/hyperbilirubinemia persisting at the time of ERC, or there was ultrasonographic evidence of duct dilatation or stones. We now believe that those with resolving 70
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biochemical abnormalities and normal ultrasound studies should not undergo ERC, and we think that this can increase our rate of positive studies. We proved choledocholithiasis in 4%, but we suspected duct stones in 11% more. Some of these latter cases may represent incorrect provisional diagnoses, but we believe that many likely represent instances of gallstone migration. Failure to accomplish duct clearance by ERC/ES preoperatively or postoperatively is a clear concern for surgeons who rely on this strategy. We have failed to visualize the common bile duct or to complete an intended ES in 1 l%, but despite this have managed a low reoperation rate of 0.2%. A second attempt at ERC/ES (with or without preliminary insertion of a facilitating transhepatic, transpapillary guidewire) should be carried out before resorting to open CBDE.‘z Evaluation must clearly identify deaths, serious complications of ERC/ES, second operations for duct stones, and serious complications from missed choledocholithiasis. The alternatives to selective ERC/ES for the management of choledocholithiasis are open and laparoscopic CBDE. The use of open CBDE results in the loss of other advantages of minimally invasive surgery, and is less attractive to most patients.36,37 Excellent results have been reported for laparoscopic CBDE, both by the transcystic approachi3j’j and by choledochotomy.‘” It has been thought that with increasing expertise in laparoscopic surgery, the use of these techniques will become widespread,ii but in fact there are large geographic areas like our own where laparoscopic CBDE is not presently practiced. These procedures are clearly more difficult than simple LC,‘6,‘h but many surgeons who have not adopted laparoscopic CBDE have meanwhile progressed to other technically demanding laparoscopic procedures. In expert hands, the operating times reported to perform _ ^ laparoscopic CBDE have ranged from 1.5 to 3.5 hours.“-’ ’ Proponents of laparoscopic CBDE have raised concerns about early morbidity and long-term effects of ERC/ ES. L3~1i,‘6~‘6Our early morbidity of 8% is comparable with other reports of 5% to 10%.“,L7.3S The only long-term sequelae documented have been late papillary stenosis and cholangitis in 6% to 13%, with follow-up of 2 to 11 years, “x4 and most have been successfully treated by repeat ES. Nevertheless, it seems prudent to minimize the number of procedures performed, and we have only used ERC/ES JULY
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for the investigation and management of duct stones in symptomatic patients. In conclusion, we believe that the selective use of ERC/ ES with LC is a strategy that competes favorably with laparoscopic CBDE for the management of choledocholithiasis. Primary open surgery for duct calculi has only occasion ally been necessary. Our morbidity has been 8% with no deaths. Our overall incidence of missed choledocholithiasis has been 2%, and secondary reoperations have been required in only 0.2%. We believe that our indications for preoperative ERC can be further refined by paying more attention to distinguishing between gallstone migration and persisting choledocholithiasis.
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