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…