Comparing the Efficacy and Safety of Holmium Laser Lithotripsy Versus Electrohydraulic Lithotripsy for the Treatment of Difficult Choledocholithiasis and Pancreatic Duct Stones: A Randomized Controlled Trial
Rush University Medical Center
Summary
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.
Description
This study aims to assess two main questions. 1: Whether low-wattage holmium:YAG laser lithotripsy (using the Quanta System Litho EVO device) is safe and effective in the management large and/or difficult bile duct or pancreatic duct stones. 2: Whether low-wattage holmium:YAG laser lithotripsy is non-inferior to electrohydraulic lithotripsy in the management of large and/or difficult gallstones. Part one of the study will investigate whether utilizing the low-wattage holmium:YAG laser lithotripsy device via single-operator cholangioscopy (SOC-LL) is safe and effective to treat large and/or di…
Eligibility
- Age range
- 19–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 19-85 years * Signed written informed consent. * Presence of one or more biliary (common bile duct or intrahepatic) or pancreatic duct stones that are deemed "difficult" based on at least one of the following criteria: * 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. * Stone located proximal to a benign biliary or pancreatic duct stricture. * Documented failure of stone extraction during a prior ERCP att…
Interventions
- DeviceLaser lithotripsy with low-wattage holmium laser
Use of low-wattage holmium laser for lithotripsy of large and/or difficult bile duct stones or pancreatic duct stones during ERCP.
- DeviceElectrohydraulic lithotripsy
Use of electrohydraulic lithotripsy for management of large and/or difficult bile duct or pancreatic duct stones.
Location
- Rush University Medical CenterChicago, Illinois