Minimal Endoscopic Sphincterotomy with Papillary Balloon Dilation Using a Novel Non-slip Balloon Catheter for the Treatment of Common Bile Duct Stones: A Prospective Pilot Study.

Background: Endoscopic sphincterotomy (ES) with minimal incision followed by balloon dilation (ESBD) is a promising hybrid technique for the treatment of common bile duct (CBD) stones. However, balloon slippage during dilation can occur easily following ES due to partially opened papillae. This study aimed to examine the clinical utility of ESBD using a novel non-slip balloon catheter.

Methods: This prospective pilot study included 100 eligible patients with CBD stones measuring ≤ 11 mm. The study outcomes included the rates of technical success, adverse events (AEs), use of mechanical lithotripsy (ML), and successful stone removal associated with ESBD using a novel balloon catheter.

Results: The procedure was performed by trainees in 93% of the study cohort. ESBD was successful in 99% of the patients, while successful ESBD on the first inflation attempt without slippage was achieved in 98% of the patients. The median procedure time for ESBD, including the 2-min dilation hold time, was 4 min. The rate of successful and complete stone removal in the first session was 98%. ML was required in 7% of the cases. The median procedure time for stone removal was 8 min. The procedure-related AE rate was 3%.

Conclusions: ESBD using the novel non-slip balloon achieved high procedural success and complete stone removal rates with very low rates of balloon slippage, AE, and ML use, even when the majority of procedures were performed by trainees.