OBJECTIVE: To evaluate the recurrence of common bile duct stones and risk factors for recurrence following routine endoscopic sphincterotomy (EST) versus small-incision endoscopic sphincterotomy plus endoscopic papillary balloon dilation (EST-EPBD). METHODS:Three hundred patients who were hospitalized between June 2007 and June 2008 with common bile duct stones >10 mm in diameter were randomly assigned to the EST or EST-EPBD group. We compared the short-term (≤3 years) and long-term (>3 years) recurrence of ductal stones in the two groups over a 72-month follow-up period. Potential risk factors were evaluated using a logistic regression analysis. RESULTS: A total of 291 patients completed the study. The short-term recurrence rate in the EST group was not significantly higher than that in the EST-EPBD group (P > 0.05). The long-term recurrence rate for the EST group was significantly higher than that for the EST-EPBD group (P < 0.05). The serum level of cholesterol, body mass index, gallstones, maximum stone diameter, number of stones, and mechanical lithotripsy were risk factors for the recurrence of ductal stones. Minimal size of the duodenal papilla incision was a protective factor with regard to the recurrence of ductal stones. Cholecystectomy, sex, and age were not associated with the recurrence of ductal stones. CONCLUSIONS: Small-incision EST-EPBD has a similar overall success rate and a significantly lower rate of the recurrence of ductal stones, compared with those of EST alone. Thus, the curative effect of EST-EPBD is better than that of EST alone. Minimal size of the duodenal papilla incision protects against the recurrence of ductal stones.
RCT Entities:
OBJECTIVE: To evaluate the recurrence of common bile duct stones and risk factors for recurrence following routine endoscopic sphincterotomy (EST) versus small-incision endoscopic sphincterotomy plus endoscopic papillary balloon dilation (EST-EPBD). METHODS: Three hundred patients who were hospitalized between June 2007 and June 2008 with common bile duct stones >10 mm in diameter were randomly assigned to the EST or EST-EPBD group. We compared the short-term (≤3 years) and long-term (>3 years) recurrence of ductal stones in the two groups over a 72-month follow-up period. Potential risk factors were evaluated using a logistic regression analysis. RESULTS: A total of 291 patients completed the study. The short-term recurrence rate in the EST group was not significantly higher than that in the EST-EPBD group (P > 0.05). The long-term recurrence rate for the EST group was significantly higher than that for the EST-EPBD group (P < 0.05). The serum level of cholesterol, body mass index, gallstones, maximum stone diameter, number of stones, and mechanical lithotripsy were risk factors for the recurrence of ductal stones. Minimal size of the duodenal papilla incision was a protective factor with regard to the recurrence of ductal stones. Cholecystectomy, sex, and age were not associated with the recurrence of ductal stones. CONCLUSIONS: Small-incision EST-EPBD has a similar overall success rate and a significantly lower rate of the recurrence of ductal stones, compared with those of EST alone. Thus, the curative effect of EST-EPBD is better than that of EST alone. Minimal size of the duodenal papilla incision protects against the recurrence of ductal stones.