Comparison of endoscopic balloon dilatation potency using balloons size more or less than 15 mm in the treatment of large bile duct stones: a clinical trial study

AIM: The present study was performed on patients with large bile duct stones to compare clinical outcomes and complications of balloon dilatation treatment between two sizes of balloons, < 15 mm and ≥ 15 mm. BACKGROUND: in 1982, the endoscopic papillary balloon dilatation (EPBD) method was presented by Staritz to reduce bleeding and perforation risk of large bile duct stones. METHODS: Patients with large bile duct stones admitted to Taleghani hospital from December 2018 to December 2019 who were the candidates for balloon dilation with limited sphincterotomy. Patients were randomly divided into two groups. In group B, a ≥ 15 mm balloon was used, and in group A, a balloon <15 mm was used. The clinical results of balloon dilation and its complications were recorded and compared. RESULTS: Most patients had 1 or 2 large bile duct stones, and there was no significant difference in the number of stones. Extraction was successful in 92.8% of group B and 85.7% of group A without significant differences (P = 0.8). Pancreatitis, hemorrhage, cholangitis, and perfusion occurred in 8%, 4.2%, 1.4%, and 2.8% of group B subjects and also in 10%, 2.8%, 0%, and 1.4% of group A subjects, respectively, and the difference between the two groups was not significant. CONCLUSION: Generally, this study results showed that balloon size did not have a significant effect on the success rate of bile duct stones. Moreover, considering the lack of significant association between balloon dilatation size and the occurrence of post-endoscopic complications such as pancreatitis, it seems that large-size dilatation has no serious clinical risk.