Feasibility and safety of intraoperative bile duct clearance by antegrade transcystic balloon sphincteroplasty: A prospective observational pilot study

Abstract

Abstract Background Concomitant cholecysto- and choledocholithiasis is common. Standard treatments are endoscopic retrograde cholangiography (ERC) followed by cholecystectomy or laparoendoscopic rendez-vous. ERC has drawbacks such as post-ERC-pancreatitis or -bleeding and potentially more than one intervention is required to address common bile duct (CBD) stones. Safety and feasibility of an intraoperative antegrade transcystic single-stage approach during cholecystectomy with balloon sphincteroplasty and pushing of stones to the duodenum has not been evaluated prospectively. The aim of this pilot study was to evaluate this procedure regarding safety, feasibility, and stone clearance rate. Methods Prospective single centre intervention study (IDEAL stage 2b). Main inclusion criteria was confirmed choledocholithiasis (stones ≤6 mm) at intraoperative cholangiography. Success of the procedure was defined as CBD stone clearance at intraoperative control cholangiography, absence of symptoms and no elevated cholestasis parameters at 6 weeks follow up. Simon’s two stage design was used to determine sample size. Results From 1/2021-4/2022, a total of 57 patients fulfilled the final inclusion criteria and were included. Mild pancreatitis or cholangitis were present upon admission in 15 (26%) and 15 (26%) patients, respectively. Median number of CBD-stones was 1 (1-6). Median stone diameter was 4 mm (0.1-6 mm). CBD stone clearance was achieved in 54 patients (94%). The main reason for failed CBD clearance was the inability to push the guidewire along the biliary stone into the duodenum. Median intervention time was 28 min (14-129 min). While there was no postoperative pancreatitis, two patients (3.5%) had asymptomatic hyperlipasaemia four hours postoperatively. Conclusions Intraoperative CBD stone clearance by antegrade balloon sphincteroplasty appears to be safe and highly feasible. Its overall superiority to the current standards warrants evaluation by a randomized controlled trial. Level of Evidence V, therapeutic/care management