Cholangioscopy-guided lithotripsy for difficult bile duct stone clearance in a single session of ERCP: results from a large multinational registry demonstrate high success rates

Background Peroral cholangioscopy (POCS) can be useful for difficult bile duct stone clearance. Large prospective multinational data on POCS-guided lithotripsy for clearing difficult bile duct stones in a single session of endoscopic retrograde cholangiopancreatography (ERCP) are missing. Methods Patients with difficult bile duct stones (defined as one or more of: largest stone diameter >= 15 mm, failed prior attempt at stone clearance, impacted, multiple, hepatic duct location, or located above a stricture) were enrolled at 17 centers in 10 countries. The principal endpoint was stone clearance in a single ERCP procedure using POCS. Results 156 patients underwent 174 sessions of POCS-guided electrohydraulic or laser lithotripsy. Stone clearance had failed in a previous ERCP using traditional techniques in 124/156 patients (80%), while 32/156 patients (21%) were referred directly to POCS-guided therapy based on preprocedural assessment of the difficulty of stone clearance. In 101/156 patients (65%), there were impacted stones. POCS-guided stone clearance was achieved in a single POCS procedure in 125/156 patients (80%, 95% confidence interval [CI] 73%-86%), and was significantly more likely for stones <= 30 mm compared with >30 mm (odds ratio 7.9, 95%CI 2.4-26.2; P=0.002). Serious adverse events occurred in 3/156 patients (1.9%, 95%CI 0.4%-5.5%), and included pancreatitis, perforation due to laser lithotripsy, and cholangitis (n=1 each), all resolved within 1 week. Conclusion POCS-guided lithotripsy is highly effective for clearance of difficult bile duct stones in a single procedure and successfully salvages most prior treatment failures. It may also be considered first-line therapy for patients with difficult choledocholithiasis to avoid serial procedures.