4653 Comparing the treatment outcomes of biliary plastic stent placement without and with endoscopic sphincterotomy for inoperable malignant common bile duct obstruction.

Background: Controversy exists regarding the use of ES to facilitate placement of 10F-PS and to reduce the risk of pancreatitis. Aim: To assess the necessity of ES before PS placement. Methods: From 3/1996 to 6/1999, 89 consecutive patients (pts)[M/F=54/35, mean age 74±6.6 years (52-87)], who underwent placement of a single 10F-polyethylene stent for inoperable malignant strictures of the common bile duct, were randomly assigned to two groups. In group A (44 pts), a limited ES was performed before PS placing. In group B, 45 pts had PS directly. Patients who had previously undergone ES, precut papillotomy, previous placement of stent or with coagulopathy were excluded. Early ( within 48 hours) complications, 30-day outcome, and late (from 30 days to stent replacement) effects were assessed. Patency interval was defined as the period between PS placement and death or obstruction. Results: Stent insertion was successful in 95% (42/44) of the pts in group A and in 91% (41/45) of the pts in group B (p>0.05). Follow-up to stent replacement was obtained in all pts. None of the stents migrated. Early complications were more frequent in the pts who underwent ES [7% (3/42) vs 2% (1/41) (p>0.05%)]: in group A pancreatitis developed in two pts and minor bleeding episode in another one, whereas pancreatitis occurred in only one patient in group B. Complications were managed conservatively. Thirty-day mortality was 6%, but no procedure-related mortality occurred. There was no significant difference in the patency interval (mean 106±45.5 days, 19-178) in the two groups (p>0.05). Stents were removed successfully in 58 pts (out of 58 still alive) for obstruction and successful of stent replacement was similar (96.5%) for both groups. Conclusion: Sphincterotomy does not seem to be necessary for placement of 10F-PS.