BACKGROUND: Endoscopic sphincterotomy (ES) for bile duct stones (BDS) can cause basket impaction with stone, complicating the procedure. In this study, we evaluated the utility and safety of small incision ES combined with endoscopic papillary balloon dilation (sES + EPBD) (balloon dilated up to the stone size), compared with ES alone for BDS <
12 mm. METHODS: The primary endpoint was the frequency of mechanical lithotripsy (ML), indicating the risk of basket impaction with stone
however, the secondary endpoints were procedure time, successful stone removal, and early adverse events. RESULTS: A total of 100 patients were randomized into the ES and sES + EPBD groups (n = 50 for each). Significantly fewer cases required ML (20.0% vs. 4.0%, p = .028) in the sES + EPBD group. The maximum short-axis diameter of the stones in all patients requiring ML in the ES group ranged from 8 to 11 mm. The median procedure time was significantly shorter (18.5 min vs. 17 min, p = .047) in the sES + EPBD group. Both groups showed similar frequencies of successful stone removal in one session (88.0% vs. 98.0%, p = .112) and early adverse events (4.0% vs. 2.0%, p = .62). CONCLUSION: In cases of small BDS, sES + EPBD exhibits a low frequency of ML, which shortens procedure time and prevents basket impaction with stones.