Endoscopic papillary large-balloon dilation with sphincterotomy for difficult common bile duct stones ≤12 mm: a prospective study.

Background: Stone recurrence is a significant complication following endoscopic bile duct clearance. Endoscopic papillary large-balloon dilation (EPLBD) with biliary sphincterotomy (EBS) has shown satisfactory results in preventing recurrence of "large" common bile duct stones (CBDS). However, data on outcomes after EPLBD+EBS for CBDS ≤12 mm remain scarce. The present study prospectively evaluated the mid- and long-term efficacy of EPLBD+EBS for CBDS recurrence among this group of patients.

Methods: Consecutive patients with CBDS ranging from 8-12 mm, treated with EPLBD+EBS from June 2018 through June 2020, were prospectively followed-up for at least 36 months. CBDS recurrence was defined as recurrent stones confirmed by endoscopic retrograde cholangiopancreatography (ERCP) during the follow-up period.

Results: Overall, 72 patients (mean age: 67 years, 52.8% male) were included, of whom 22 (30.5%) had multiple (≥3) CBDS, 23 (31.9%) had a history of cholecystectomy, 13 (18.1%) had a periampullary diverticulum and 22 (30.5%) had a previous EBS. The mean CBD diameter was 11.6±1 mm, while a tapered duct was noted in 7 (9.7%). Post-procedural bleeding and cholangitis occurred in 1 and 2 cases respectively. No cases of perforation and post-ERCP pancreatitis were observed. During a mean follow up of 46.4±6.2 months (range 37-60), no mid-term recurrence was observed, whereas CBDS recurred in 2/72 (2.7%) in the long term.

Conclusions: EPLBD+EBS in patients with CBDS ≤12 mm was associated with a very low rate of mid- and long-term CBDS recurrence. Our results need to be further investigated with randomized controlled trials.