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

Conditions

• Choledocholithiasis
• Pancreatic Duct Stone

Eligibility Criteria

Sex

ALL

Age

19 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Laser lithotripsy with low-wattage holmium laser — DEVICE
  Use of low-wattage holmium laser for lithotripsy of large and/or difficult bile duct stones or pancreatic duct stones during ERCP.
• Electrohydraulic lithotripsy — DEVICE
  Use of electrohydraulic lithotripsy for management of large and/or difficult bile duct or pancreatic duct stones.

Study Details

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.

Key Dates

Start date

Jan 15, 2026

Status verified

Feb 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Laser Lithotripsy
  Laser lithotripsy (LL). Use of LL to break down large/difficult bile duct or pancreatic duct stones.
• Active Comparator: Electrohydraulic Lithotripsy
  Electrohydraulic lithotripsy (EHL). Use of EHL to break down large/difficult bile duct or pancreatic duct stones.

Primary Outcome Measure

Complete stone clearance [ Time Frame: Immediately after the procedure ]

Central Contacts

• Neal A Mehta, MD
  3129428651
  [email protected]
• Amanda Lin, DSc, CCRC
  [email protected]

Locations (1)

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