SURGERY VS ENDOSCOPY AS PRIMARY-TREATMENT IN SYMPTOMATIC PATIENTS WITH SUSPECTED COMMON BILE-DUCT STONES - A MULTICENTER RANDOMIZED TRIAL

Objective: To compare surgical treatment (ST) with endoscopic manageme nt (EM) in patients with suspected common bile duct stones. Patients: Two hundred twenty eligible patients originating from 18 surgery units . Patients enrolled in this multicenter randomized study had clinical symptoms that included jaundice, mild pancreatitis (Ranson score less than or equal to 2), or mild acute cholangitis; biliary colic (with in creased alkaline phosphatase levels); and common bile duct stones or a common bile duct diameter of 1 cm or larger on ultrasonography. Metho ds: Two hundred two patients were randomly assigned to either ST (n = 105) or EM (n = 97) during a 5-year period. Both groups were comparabl e with respect to age, sex, American Society of Anesthesiologists scor e, and clinical presentation. Main Outcome Measures: The rates of earl y postoperative additional procedures necessary to deal with the impos sibility to perform the initial procedure, complications, and retained stones after ST or EM. Subsidiary endpoints were intention-to-treat a nalyses of mortality and of major complications and the duration of ho spital stay. Results: Surgical treatment was associated with a signifi cantly (P< 001) lower rate of 1 or 2 additional procedures (8% vs 29%) due to a significantly lower rate of the impossibility to perform the initial procedure (0% vs 5%) (P<.05), major complications (4% vs 13%) (P<.05), and retained stones (6% vs16%) (P<.04). Minor complications occurred more often in patients having ST (4%) than in those having EM (0%) (P<.01). Cholecystectomy was performed routinely in 102 patients having ST and electively in 36 patients having EM. There was 1 death in each group initially. On an intention-to-treat analysis, 3 deaths ( 3.1%) occurred after EM and 1 (0.9%) after ST; this difference was not statistically significant (P = .56). Major com plications occurred in 4% of patients having ST compared with 11% of patients having EM (P<. 002). The median duration of hospital stay was 16 days in patients hav ing ST and 12 days in those having EM; this difference was not statist ically significant (P =.09). Conclusion: Whether an additional cholecy stectomy is performed routinely or electively, the high risk of additi onal procedures after EM precludes its use as the optimal therapy in p atients with symptomatic common bile duct stones, except in those with severe cholangitis.