The goal of this clinical trial is to learn if a low-power holmium laser works to treat large and/or difficult bile duct or pancreatic duct stones in adults. It will also learn about the safety of the low-wattage holmium laser. The main questions it aims to answer are:
Is the low-power holmium laser effective at treating large and/or difficult bile duct or pancreatic duct stones? Is the low-power holmium laser effective safe to use in adults? How does the low-power holmium laser compare to electrohydraulic lithotripsy for the management of large and/or difficult bile duct or pancreatic duct stones.
Participants will:
Undergo ERCP procedure and their bile duct or pancreatic duct stone will either be broken up with the low-power holmium laser lithotripsy device or the electrohydraulic lithotripsy lithotripsy device.
Answer a call 30 days after the procedure to document symptoms and/or any side effects.
Age 19-85 years
Signed written informed consent.
Stone diameter ≥ 15 mm in any single dimension as measured on prior cross-sectional imaging (CT, MRCP, or EUS).
Presence of an impacted stone that cannot be dislodged with a standard balloon or basket.
Pregnancy: Repeated ERCP would be delayed until after delivery if possible
Clinically significant, uncorrectable coagulopathy (defined as INR > 1.5 or platelet count < 50,000/μL).
Surgically altered upper gastrointestinal anatomy that precludes conventional ERCP access (e.g., Roux-en-Y gastric bypass), unless an alternative access route (e.g., laparoscopy-assisted or EUS-directed) is planned as the standard of care.
Known or highly suspected malignant biliary or pancreatic stricture associated with the stone.
Parallel
Laser lithotripsy with low-wattage holmium laser
DeviceUse of low-wattage holmium laser for lithotripsy of large and/or difficult bile duct stones or pancreatic duct stones during ERCP.
Electrohydraulic lithotripsy
DeviceUse of electrohydraulic lithotripsy for management of large and/or difficult bile duct or pancreatic duct stones.
Complete stone clearance
Complete stone clearance is defined as the lithotripsy and clearance of ductal stone fragments as confirmed on cholangiogram or pancreaticogram at the end of the index/first procedure of the study.
Overall complete stone clearance rate
This describes the rate of complete stone clearance at the end of the final procedure required to completely clear stones, regardless of the number of procedures required to do so.
Number of procedures
Describes the number of ERCP procedures required to achieve complete stone clearance.
Total procedure time
Total duration of index ERCP procedure. Will also document total procedural time for all necessary ERCPs to achieve stone clearance.
Total lithotripsy time
Duration of the activation time for either the laser lithotripsy or the electrohydraulic lithotripsy devices during the study duration.
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