ArticlesWait-and-see policy or laparoscopic cholecystectomy after endoscopic sphincterotomy for bile-duct stones: a randomised trial
Introduction
Endoscopic sphincterotomy is widely accepted as the treatment of choice for patients with common bile-duct stones.1, 2, 3 Stone extraction is successful in up to 97% of patients,3, 4, 5 with a procedure-related morbidity of 5·8% and a mortality rate of 0·2%.3 Whether subsequent laparoscopic cholecystectomy is indicated in patients with concomitant gallbladder stones—to prevent biliary complications such as biliary colics, acute cholecystitis, or recurrent common bile-duct stones with cholangitis or biliary pancreatitis—remains a matter of debate. In several retrospective and prospective non-randomised studies, researchers have shown that only 4–12% of patients who are not operated on develop biliary complications during follow-up.1, 2, 4, 6, 7, 8
Risk factors for development of at least one recurrent biliary event after endoscopic sphincterotomy have been reported, such as multiple small gallbladder stones, a non-patent cystic duct, cholangitis upon presentation, and young age.9 However, reports are controversial, and the decision whether to operate or not seems largely empirical. In an evaluation of all patients who had been referred for endoscopic sphincterotomy for common bile-duct stones,10 referring surgeons were more likely to advise subsequent cholecystectomy, whereas gastroenterologists managed more patients expectantly, though there was no difference in age and comorbidity between both groups.
To assess whether a wait-and-see policy after endoscopic sphincterotomy is justified, we did a randomised trial in which we compared elective laparoscopic cholecystectomy with a wait-and-see policy after successful endoscopic sphincterotomy and extraction of common bile-duct stones.
Section snippets
Patients
We recruited patients from the Departments of Surgery and Gastroenterology of the Academic Medical Center, Amsterdam, and from eight other Dutch Community Hospitals. All patients between 18 and 80 years of age, who underwent successful endoscopic sphincterotomy and extraction of common bile-duct stones and who had radiologically proven stones in the gallbladder, were eligible for the trial. We excluded patients who were not fit for surgery (ie, ASA IV and V). We asked all consecutive patients
Results
Between September, 1995, and April, 1999, 120 patients were recruited (figure 1). 56 patients were randomly allocated to laparoscopic cholecystectomy and 64 to a wait-and-see policy. Since initial endoscopic sphincterotomy was often done in an acute setting outside regular working hours, information about patients who were eligible for the trial but who were not randomly allocated was incomplete. However, 66 of 120 patients were randomly allocated in one hospital (Academic Medical Center);
Discussion
We showed that 47% (27/59) of expectantly managed patients (wait and see) developed at least one recurrent biliary event after sphincterotomy during 2 years of follow-up, compared with 2% (1/49) of patients who underwent laparoscopic cholecystectomy. The absolute risk reduction of laparoscopic cholecystectomy is 45%. Thus, the low recurrence rate (5–12%) of biliary-related events during follow-up after sphincterotomy, with gallbladder in situ, as reported in many retrospective studies with
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