Endoscopic Large-balloon Sphincteroplasty Without Preceding Sphincterotomy for the Removal of Large Bile Duct Stones: a Preliminary Study

Background: Endoscopic sphincterotomy (EST) has usually been performed before large-balloon sphincteroplasty (LBS) to retrieve large bile duct stones because of the high risk of pancreatitis and some advantages of EST. However, there are no available data on the preceding EST to confirm these assertions.

Objective: We investigated the safety and efficacy of LBS without a preceding EST for the management of large bile duct stones.

Design: Single-institution retrospective study.

Setting: Tertiary referral center.

Patients: Thirty-eight patients with large bile duct stones.

Interventions: Endoscopic LBS without preceding EST.

Main Outcome Measurements: Efficacy of stone removal and complications related to the procedure.

Results: The overall success rate irrespective of whether mechanical lithotripsy (ML) was used was 97.4% (37/38). Complete duct clearance by LBS alone without ML was achieved in 29 (76.3%) patients. Complete stone retrieval was achieved by LBS alone in the first session in 25 (65.8%) patients. ML was required in 8 (21.1%) patients. Failure to extract a stone occurred in 1 (2.6%) patient. There was a mild degree of postprocedure pancreatitis in only 1 (2.6%) patient and asymptomatic hyperamylasemia in 3 (7.9%) patients. The maximum diameters of the stones and the balloon/stone diameter ratio had a tendency to affect complete stone retrieval in the success and failure groups: 16.7 +/- 3.9 mm vs 20.8 +/- 6.5 mm and 0.96 +/- 0.19 mm vs 0.80 +/- 0.23 mm, respectively (results are presented as mean +/- standard deviation).

Limitations: Small-scale, single-arm study.

Conclusions: Our data suggest that LBS without EST is safe and effective in patients with large bile duct stones.