Comparing the Efficacy and Safety of Holmium Laser Lithotripsy Versus Electrohydraulic Lithotripsy for the Treatment of Difficult Choledocholithiasis and Pancreatic Duct Stones

Inclusion Criteria:

• Age 19-85 years

• Signed written informed consent.

• Presence of one or more biliary (common bile duct or intrahepatic) or pancreaticduct stones that are deemed "difficult" based on at least one of the followingcriteria:

• Stone diameter ≥ 15 mm in any single dimension as measured on priorcross-sectional imaging (CT, MRCP, or EUS).

• Presence of an impacted stone that cannot be dislodged with a standard balloonor basket.

• Stone located proximal to a benign biliary or pancreatic duct stricture.

• Documented failure of stone extraction during a prior ERCP attempt usingstandard techniques (e.g., sphincterotomy with balloon/basket extraction).

Exclusion Criteria:

• Pregnancy: Repeated ERCP would be delayed until after delivery if possible

• Clinically significant, uncorrectable coagulopathy (defined as INR > 1.5 or plateletcount < 50,000/μL).

• Surgically altered upper gastrointestinal anatomy that precludes conventional ERCPaccess (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 withthe stone.

• Acute pancreatitis at the time of screening, unless it is gallstone pancreatitiswith persistent biliary obstruction, for which ERCP is therapeutically indicated.

• Severe cardiopulmonary disease or other comorbidities that, in the judgment of theinvestigator, would make the patient an unsuitable candidate for a prolongedendoscopic procedure under general anesthesia.

• Known life expectancy of less than 6 months.

• Inability or unwillingness to comply with study procedures or follow-uprequirements.