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.