Orlando protocol for single session ductal clearance of common bile duct stones at ERCP.

OBJECTIVES: Approach to management of common bile duct stones (CBDS) by endoscopic retrograde cholangiopancreatography (ERCP) is not standardized. We examined outcomes by applying predetermined protocol for CBDS management.

METHODS: When standard extraction techniques failed at ERCP, presence of tapered bile duct and stone-duct ratio were calculated. Large balloon sphincteroplasty (LBS) and/or mechanical (ML)/single-operator cholangioscopy-guided lithotripsy (SOCL) was performed based on presence of tapered bile duct and stone-duct mismatch. Primary outcome was single-session ductal clearance. Secondary outcome was adverse events.

RESULTS: Of 409 patients treated over 16 months, 321 (78.5%) had no tapered bile duct or stone-duct mismatch and single-session ductal clearance was achieved using standard techniques in 99.7% over median duration of 14 minutes (IQR 9-21 mins). Of 88 (21.5%) patients with difficult CBDS, tapered duct was seen in 79 (89.8%) and/or stone-duct mismatch in 36 (40.9%). Single-session ductal clearance was achieved in all 88 patients (100%) by LBS in 79 (89.8%), ML in 20 (22.7%) and SOCL in 16 (18.2%) over median duration of 29 minutes (IQR 17-47 mins). Overall, single-session ductal clearance was achieved in 99.8% with adverse events in 17 (4.2%) that included perforation in 2, post-sphincterotomy bleeding in 1, and mild/moderate post-ERCP pancreatitis in 14 patients.

CONCLUSIONS: A predetermined protocol optimized outcomes by enabling single-session ductal clearance of CBDS with high technical success and low adverse events.