Surgery vs Endoscopy as Primary Treatment in Symptomatic Patients With Suspected Common Bile Duct StonesA Multicenter Randomized Trial

Abstract

WHEN choledocholithiasis is associated with acute pancreatitis, a recent trial has shown that endoscopic sphincterotomy (ES) was not superior to conventional treatment, as regards overall mortality, mortality due to pancreatitis, and complications.¹ In patients with severe pancreatitis, early ES (either 2 or 72 hours). In patients with severe cholangitis, endoscopic drainage is superior to surgery.⁴ In other types of symptomatic choledocholithiasis, ie, with jaundice, mild pancreatitis, mild cholangitis, or biliary colic with biochemical signs of cholestasis, 2 therapeutic options are presently available, namely, surgical treatment (ST) and endoscopic management (EM). The latter includes endoscopic retrograde cholangiopancreatography (ERCP) associated with ES and the extraction of stones whenever found. At least 6 controlled trials^5-10 have shown that immediate mortality was not significantly different, ranging from 0% to 4% in patients having ST and from 0% to 6% in patients having EM. Endoscopic management would be a valuable therapeutic alternative if the gallbladder could be left in situ.^7-9 When the gallbladder is left in situ, however, 20%⁷ to 40%^8,9 of patients will require a second operation for biliary complications in the months or years after EM. Two operative strategies have been proposed to avoid these risks, early routine cholecystectomy either during the same hospital admission^5-7,10 or only when necessary.^8,9 To choose the better of the 2 strategies, the rate and the risks of early additional procedures must be known. "Early additional procedures" are defined as those necessary to do because of the impossibility of performing the initial procedure, complications, and retained stones (including either repetition of the initial procedure or the necessity of another procedure). Additional procedures are associated with a second anesthesia and a second intervention, both representing extra costs and risks. For these reasons, it appeared necessary to compare the early results of ST and EM on an intention-to-treat basis in a multicenter trial controlled by randomization.