Long-term outcomes of endoscopic papillary large-balloon dilation (12–15 mm) with or without limited sphincterotomy for removal of bile duct stones

Limited endoscopic sphincterotomy with large balloon dilation (ES-LBD) and endoscopic papillary large-balloon dilation (EPLBD) have been proven safe and effective for removal of bile duct stones . However, the long-term outcomes are not clear. The aim of this study was to assess the long-term outcomes of EPLBD (12–15 mm) with or without limited sphincterotomy for removal of common bile duct (CBD) stones. Patients with EPLBD or ES-LBD referred for the removal of bile-duct stones between June 2008 and August 2020 were retrospectively reviewed. Complete stone clearance, endoscopic retrograde cholangiopancreatography (ERCP)-related adverse events, and late biliary complications during long-term follow-up were analyzed. Basic patient characteristics were not significantly different between the groups that underwent EPLBD ( n = 168) and ES-LBD ( n = 57). EPLBD compared with ES-LBD resulted in similar outcomes in terms of overall successful stone removal (99.4% vs. 100%, P = 1.00) and ERCP-related adverse events (7.7% vs. 5.3%, P = 0.77). The mean duration of the follow-up was 113.6 months and 106.7 months for patients with EPLBD and ES-LBD, respectively ( P = 0.13). There was no significant difference between EPLBD and ES-LBD in the incidence of stone recurrence [20 (11.9%) vs. 9 (15.8%); P = 0.49]. Multivariate analysis showed that a diameter of CBD ≥ 15 mm (OR = 3.001; 95% CI: 1.357–6.640; P = 0.007) was an independent risk factor for stone recurrence. The application of a large balloon (12–15 mm) via EPLBD is an effective and safe alternative to ES-LBD for extraction of large CBD stones. Endoscopic sphincterotomy prior to EPLBD may be unnecessary. A diameter of CBD ≥ 15 mm is a risk factor of stone recurrence.