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Aim: Considerable controversy surrounds the adoption of endoscopic sphincterotomy (ES) to facilitate the placement of 10F plastic stents (PS) and to reduce the risk of pancreatitis The aim of the study was to assess the possible advantages of ES before PS placement., Methods: From 3/1996 to 6/2001, 172 consecutive patients, who underwent placement of a single 10F- polyethylene stent for inoperable malignant strictures of the common bile duct, were randomly assigned to 2 groups. In group A (96 patients), a ES was performed before PS placement In Group B, 96 patients had PS directly. Early complications (within 30 d) and late effects (from 30 d to stent replacement) were assessed. Patency interval was defined as the period between PS placement and obstruction or death. The success of stent replacement in the 2 groups was evaluated., Results: Stent insertion was successful in 95.8%(92/96) of the pts in group A and in 93.7%(90/96) of the patients in group B (P>0.05). Early complications were more frequent in patients who underwent ES (6.5% vs 4.4%) but the data were not significant (P>0.05). In group A pancreatitis developed in two patients and bleeding in three; whereas pancreatitis occurred in 2 patients in group B. Complications were managed conservatively. No procedure related mortality occurred. All late complications were acute cholangitis due to stent occlusion. We performed a stent replacement in 87 patients that was successful in 84 cases without differences between groups., Conclusion: Sphincterotomy does not seem to be necessary for placement of 10F-PS in patients with malignant common bile duct obstruction.