Randomized trial of cholangioscopy-guided laser lithotripsy versus conventional therapy for large bile duct stones (with videos).

BACKGROUND AND AIMS: Bile duct stones >1 cm have a decreased incidence of successful endoscopic extraction and often require lithotripsy. Although previous guidelines suggested mechanical lithotripsy for large common bile duct stones, current guidelines suggest cholangioscopy-guided lithotripsy as an adjunct with or without balloon dilation or mechanical lithotripsy. However, no randomized trials have assessed the usefulness of this practice.

METHODS: Patients with bile duct stones >1 cm in diameter were randomized in a 2:1 ratio to cholangioscopy-guided laser lithotripsy versus conventional therapy only. Conventional therapies such as mechanical lithotripsy or balloon dilation were also allowed in the laser lithotripsy group. Randomization was stratified by history of ERCP in the past 3 months. The primary outcome was endoscopic clearance of the bile duct stones.

RESULTS: Endoscopic clearance was achieved in 39 (93%) of 42 patients treated with cholangioscopy-guided laser lithotripsy and 12 (67%) of 18 treated with conventional therapy only (P = .009). The 9 patients in whom ERCP was unsuccessful underwent surgical common duct exploration with stone removal. Mean procedure time was 120.7 ± 40.2 minutes for the cholangioscopy-guided laser lithotripsy group compared with 81.2 ± 49.3 minutes for the conventional therapy group (P = .0008). There was no significant difference in fluoroscopy time, number of procedures, or adverse events (cholangitis) (cholangioscopy, 2; conventional, 1) and post-ERCP pancreatitis (cholangioscopy, 2; conventional, 1).

CONCLUSION: Cholangioscopy-guided laser lithotripsy increases the incidence of endoscopic clearance of large bile duct stones and decreases the need for surgery compared with conventional therapy alone. However, it is associated with longer procedure times. (Clinical trial registration number: NCT0175997.).