Background: The large CBD stone is challenge for endoscopist to remove, because it would be difficult when using the standard technique. We herein performed a prospective randomized controlled trial comparing clinical outcomes including efficacy and complications of EPLBD versus ML in patients with “difficult” CBD stones.

Methods: Sixty patients at the NKC Institute of Gastroenterology and Hepatology, Songkla University, who met the diagnostic criteria for large CBD stones, were undergone ES and then randomized to EPLBD and ML groups. The success rate, complication rates and procedure time were compared between 2 groups.

Results: Sixty patients were diagnosed large CBD stones. Thirty one patients were randomized to EPLBD and 29 patients to ML. Four patients were excluded from each group and remain 27 (51.9%) patients in EPLBD group and 25 (48.1%) patients in ML group. The baseline characteristics including age, sex, comobidities, blood chemistry were not significant between both groups. By the first ERCP session, the complete stone removal rates were 66% in EPLBD group and 76% in ML group (p = 0.05). After crossover 5 from 8 patients and 4 from 5 patients were achieved complete stone removal by ML and EPLBD, respectively. The procedure time in successful stone removal session seem to be shorter in EPLBD group (12.25 ฑ 4.1 vs. 17.52 ฑ 10.53 minutes in EPLBD and ML groups, respectively) (p = 0.037). None developed acute pancretitis, but three patients (11.1%) developed mild, self-limited bleeding in EPLBD group. One patient developed post-ERCP cholangitis due to retained fragment stones which needed second ERCP. Self-limited bleeding from ES was occured in 2 patients (7.4%) from EPLBD group and 1 patient (4%) from ML group. There was no procedure related death, but one patient in ML group was dead from cholangiocarcinoma during long term follow up.

Conclusion: In difficult CBD stone, EPLBD consumed less procedure time while provided comparable effectiveness and complication rates with ML. EPLBD should be considered as an alternative procedure for removal of difficult CBD stones.