Ductal occlusion by intracanal injection of fibrin glue decreases neither the rate nor the severity of intra-abdominal complications after pancreatic resection.
To compare surgical treatment (ST) with endoscopic management (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 Յ2), or mild acute cholangitis; biliary colic (with increased alkaline phosphatase levels); and common bile duct stones or a common bile duct diameter of 1 cm or larger on ultrasonography. Methods: Two hundred two patients were randomly assigned to either ST (n = 105) or EM (n = 97) during a 5-year period. Both groups were comparable with respect to age, sex, American Society of Anesthesiologists score, and clinical presentation. Main Outcome Measures: The rates of early postoperative additional procedures necessary to deal with the impossibility to perform the initial procedure, complications, and retained stones after ST or EM. Subsidiary endpoints were intention-to-treat analyses of mortality and of major complications and the duration of hospital stay. Results: Surgical treatment was associated with a significantly (PϽ.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%) (PϽ.05), major complications (4% vs 13%) (PϽ.05), and retained stones (6% vs 16%) (PϽ.04). Minor complications occurred more often in patients having ST (4%) than in those having EM (0%) (PϽ.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 complications occurred in 4% of patients having ST compared with 11% of patients having EM (PϽ.002). The median duration of hospital stay was 16 days in patients having ST and 12 days in those having EM; this difference was not statistically significant (P = .09).
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