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Management of Choledocholithiasis in the Laparoscopic Era S e e article on page 2 5 2 .
he treatment of a patient scheduled for elective cholecystectomy who has choledocholithiasis or indications of choledocholithiasis was nicely worked out by the time that laparoscopic cholecystectomy came along. The technique of open common bile duct exploration (OCBDE) had been developed and refined over 100 years, and it was a safe and effective method of removing bile duct stones found at cholecystectomy. About a decade ago, it was thought that preoperative endoscopic retrograde cholangiopancreatography (ERCP) combined with cholecystectomy might be superior to cholecystectomy and OCBDE, but this was not substantiated in randomized trials. 1 4 Then "lap chole" was introduced, and overnight the value of accumulated knowledge on the management of choledocholithiasis in this situation plummeted. If laparoscopic cholecystectomy had been only a moderately important advance, it might have been possible to continue to use OCBDE in patients with duct stones found at surgery. However, the advantages of reduced pain, rapid discharge from hospital, quick return to normal activity and employment, and improved cosmesis 5 literally had to be seen to be believed. As a result, both patients and physicians wanted to maintain the minimally invasive nature of the procedure; consequently, alternatives for OCBDE were sought. When laparoscopic cholecystectomy was introduced, there was no method for laparoscopic bile duct exploration, but detection and treatment of stones by ERCP meant that all the advantages of laparoscopic cholecystectomy could be retained when choledocholithiasis was present. The question then became when to perform ERCP and for what indications. Preoperative ERCP had the advantage that OCBDE could still be performed if all stones could not be removed preoperatively; if one waited until after surgery to perform the ERCP and it failed, a second operation to remove the stones would probably be needed. On the other hand, postoperative ERCP had the advantage of being associated with fewer negative ERCP results, because the presence or absence of stones could be ascertained by operative cholangiography at surgery. At first, some centers practiced routine preoperative ERCP, but the negative ERCP rate was so high that this was abandoned. Most centers performed preoperative ERCP only on patients at high risk for choledocholithi-
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asis. High risk initially meant patients with abnormal liver function test results or dilated bile ducts detected by ultrasonography, jaundiced patients, patients with demonstrated stones, or patients who had had pancreatitis. Gradually these criteria were refined, and prognostic scoring systems were developed. 6 9 A number of studies using such criteria have been published, presenting very similar results. 1°-15 About 10% of patients requiring elective cholecystectomy met the refined criteria for preoperative ERCP; about half of them had stones, and the other half had negative ERCP findings. ERCP was very successful in removing stones when they were found. However, in these six studies involving about 5000 patients, the actual stone rate was 5%. If this policy were continued, there would be about 30,000 ERCPs with negative results performed annually in this country in the 600,000 patients scheduled for laparoscopic cholecystectomy. Therefore, there has been a gradual move away from preoperative ERCP, especially in centers where expertise was such that stones could almost certainly be removed by postoperative ERCP. In these centers, the indications for preoperative ERCP were reduced to jaundice and demonstrated stones. Even prior gallstone pancreatitis fell out as an indication because most of these patients had negative ERCP findings. 16 18 Abnormal liver function test results, dilated ducts, and prior pancreatitis became indications for operative cholangiography rather than preoperative ERCP, and, if stones were found, they were removed by postoperative ERCP. In other centers with less confidence in postoperative ERCP, the less restrictive criteria for ERCP have been retained. OCBDE is also still used in some hospitals in which confidence in ERCP is lacking and laparoscopic bile duct exploration (LCBDE) is not available. OCBDE is certainly still an acceptable technique, although expertise in this method will decrease in the future. Although there was no technique for LCBDE in 1989, techniques have been developing rapidly and are becoming widespread. The main method is to deal with the stones through the cystic duct, so-called "transcystic" method. The simplest technique is to flush stones after dilating the sphincter of Oddi with a muscle relaxant like glucagon. This works reasonably well for very small stones. When flushing fails, baskets can be radiologically maneuvered in the bile duct or a choledochoscope can be introduced, and the stones can be removed after basketing under direct vision. Sometimes balloon dilatation of the cystic duct is needed. The technique works very well; about 500 patients have been reported in several
July 1 9 9 5
series with successful clearance achieved in over 95% of c a s e s . 19-23 Limitations of this technique are that it is difficult to deal with large numbers of stones, with stones > 8 m m in diameter, and with intrahepatic stones. Another limitation is that, in some instances of choledocholithiasis, a sphincterotomy is indicated; presently, this cannot be performed laparoscopically in most institutions. However, such techniques are being developed. 24'25 Therefore, in centers competent in transcystic explorations, the indication for preoperative ERCP has been further reduced to jaundice and situations in which the stones will be difficult to remove by LCBDE. This is the present policy on our service. Formal incision of the duct by a laparoscopic technique, much as with OCBDE, has also been introduced in a few centers. It makes dealing with difficult stones possible but is a much more challenging procedure currently. 21'23With refinements, it could become the procedure of choice. Intraoperative ERCP has also been described. 26 In summary, the trend, recently summarized and analyzed by us, 2v has been to gradually move away from preoperative ERCP to transcystic duct exploration and postoperative ERCP when that fails. The preceding discussion is based exclusively on case series. The changes in practice have occurred through an iterative process based on such case series, presentations at medical conferences, and personal experience. Until now, there have been no formal studies. In this issue of GASTROENTEROLOGY, Erickson and C a r l s o n 28 present a decision analysis on the question of timing of ERCP. The study is well performed. The sensitivity analysis provides confidence that conclusions are warranted even if the true values deviate somewhat from the estimates. Estimates are critical in determining outcome of such analyses, and we must point out that costs in this study were estimated from current charges rather than determining actual costs. There is not necessarily a close relationship between charge and cost; this may be a source of error in this study. We also feel that the estimate of 12% for patients who have stones in the duct is too high. As noted above, the real value today is probably about 5 % ) °-15 Although the study is convincing and a welcome addition to this rather unstructured area, we have a few critical comments to make. W e are somewhat disappointed that Erickson and Carlson watered down the principal conclusion of their study, that postoperative ERCP is superior to preoperative ERCP, by adding that the differences were small and that the result was in reality a decision analysis "toss-up." The effect of this statement, which will be widely quoted (unfortunately, we believe), will be to encourage continuance of preoperative ERCP, which by the authors' estimate has negative findings 60% of the time, in agreement with our own estimates.
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Erickson and Carlson report a cost saving of the postoperative ERCP strategy over the preoperative one of about $260 per patient undergoing cholecystectomy or about $150 million per year in this country alone. If there has been a decision to "toss-up" this kind of cash, let us know, and we'll be right there to catch it. The failure to include LCBDE as an option in the analysis is a shortcoming. There is enough literature to provide the necessary estimates; as noted above, laparoscopic exploration has become a reality in many centers. The citation of Hunter's 1992 paper 29 by the authors to the effect that techniques for LCBDE are not widely available is a weak reason because, in this field, 1992 was the middle ages, and there are now many reports of laparoscopic explorations. The authors note that had they entered laparoscopic exploration as an option, it probably would have been equal or superior to the other options. W e agree, as noted in our less formal analysis. 27 W e also question the unsupported statement that many community surgeons still have ERCP performed before laparoscopic cholecystectomy. This may be the case, but there has been no analysis of what is happening in community hospitals overall. Many community hospitals are now equipped to perform LCBDE. W e agree strongly with the authors that results of ERCP and laparoscopic exploration depend on expertise and experience and therefore strategies must be modified based on available experience. As we have noted, 2v experience and expertise permit reliance on laparoscopic exploration and postoperative ERCP, whereas the lack of these factors favor preoperative ERCP and open exploration. Randomized trials are needed. The authors comment on the difficulty of performing these trials. Yet, randomized trials of open exploration vs. ERCP have been performed. 1-4 Randomized trials of laparoscopic exploration vs. laparoscopic detection and postoperative ERCP are needed. By no means is it clear which strategy is superior. Evaluations of case series either informally, as we have done, 26 or by a formal method like decision analysis has limitations. Conclusive information can only be obtained by randomized trials. STEVEN M. STRASBERG NATHANIEL J. SOPER Section of Hepatoailiary-Pancreatic Surgery Washington University School of Medidne St. Louis, Missouri
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Address requests for reprints to: Steven M. Strasberg, M.D., Department of Surgery, Washington University School of Medicine, Queery Tower, Room 6107, Box 8109, 660 South Euclid Avenue, St. Louis, Missouri 63110. @ 1995 by the American Gastroenterological Association 0016-5085/95/$3.00