Digital cholangioscopy-guided laser versus mechanical lithotripsy for large bile duct stone removal after failed papillary large-balloon dilation: a randomized study

Abstract Background Endoscopic papillary large-balloon dilation (EPLBD) allows for the complete removal of large common bile duct (CBD) stones without fragmentation; however, a significant proportion of very large stones and stones floating above a tapering CBD require lithotripsy. Mechanical lithotripsy and cholangioscopy-guided laser lithotripsy are both effective for stone fragmentation. This study aimed to directly compare, for the first time, the efficacy of these two techniques in terms of stone clearance rate, procedure duration, patient radiation exposure, and safety. Methods 32 patients with very large CBD stones or with stones floating above a tapering CBD, and in whom extraction after standard sphincterotomy and/or EPLBD had failed, were randomly assigned to mechanical lithotripsy or cholangioscopy-guided laser lithotripsy at two tertiary referral centers. Crossover was allowed as a rescue treatment if the assigned technique failed. Results Patients’ demographic data were not different between the two groups. Mechanical lithotripsy had a significantly lower stone clearance rate in the first session compared with laser lithotripsy (63% vs. 100%; P < 0.01). Laser lithotripsy rescued 60% of patients with failed mechanical lithotripsy by achieving complete stone clearance within the same session. Radiation exposure of patients was significantly higher in the mechanical lithotripsy group than in the laser lithotripsy group (40 745 vs. 20 989 mGycm2; P = 0.04). Adverse events (13% vs. 6%; P = 0.76) and length of hospital stay (1 vs. 1 day; P = 0.27) were not different. Conclusions Although mechanical lithotripsy is the standard of care for a very large CBD stone after failed EPLBD, where available, cholangioscopy-guided laser lithotripsy is considered the better option for the treatment of this entity as it provides a higher success rate and lower radiation exposure.