Feasibility and Safety of Intraoperative Bile Duct Clearance by Sphincter Oddi Balloon Dilatation: A Prospective Observational Pilot Study

Abstract

Background Concomitant cholecysto- and choledocholithiasis is common. Standard treatments are ERCP followed by cholecystectomy or laparoendoscopic rendez-vous. ERCP has drawbacks such as post-ERCP-pancreatitis (5%) or -bleeding (5%) and potentially more than one intervention to address common bile duct (CBD) stones. Safety and feasibility of an intraoperative antegrade transcystic single-stage approach during cholecystectomy with papillary balloon dilation and pushing of concrements to the duodenum has not been evaluated prospectively. Aims The aim of the study was to evaluate this procedure regarding safety and stone clearance rate. Methods Prospective single centre intervention study. 80 consecutive patients admitted to our institution between 1/2021 and 4/2022 with suspected or confirmed choledocholithiasis (stones ≤ 6 mm) and known cholecystolithiasis were included. Success of the procedure was defined as lack of filling defects in the intraoperative control cholangiography and absence of symptoms at 6 weeks follow up. Simon's two stage design was used to determine sample size. Aiming for 95% positive outcomes (no pancreatitis) and tolerating at most 15% negative outcomes, power analysis revealed 57 participants (80% power, alpha 0.05). Results 57/80 patients (71%) fulfilled the inclusion criteria. While there was no postoperative pancreatitis, 2 patients (3.5%) had asymptomatic amylasemia 4h postoperatively. Stone clearance was achieved in 54 patients (94%). The main reason for failed stone clearance was the inability to push the guide wire along the concrement into the duodenum. Median number of CBD-stones was 1 (1-6). Median stone diameter was 4 mm (0.1-6 mm). Median intervention time was 28 min (14-129 min). Conclusions Intraoperative bile duct clearance by balloon dilation of the sphincter Oddi appears to be safe and highly feasible. Its overall superiority to the current standards requires evaluation in a randomized controlled trial.