Evaluating Low-Wattage Holmium Laser Versus Electrohydraulic Lithotripsy for Treating Large or Difficult Bile Duct and Pancreatic Duct Stones in Adults

What this Trial Is About

This research aims to evaluate the use of a low-power holmium laser to treat large andor difficult stones in the bile duct or pancreatic duct in adults. It also seeks to assess the safety of this low-wattage holmium laser and compare its performance to electrohydraulic lithotripsy for managing these challenging stones. The study is designed as a randomized controlled trial to answer these important questions. Participants will undergo an ERCP endoscopic retrograde cholangiopancreatography procedure where their bile duct or pancreatic duct stones will be broken up using either the low-power holmium laser lithotripsy device or the electrohydraulic lithotripsy device. The study includes two groups one receiving laser lithotripsy and the other receiving electrohydraulic lithotripsy. The procedures use single-operator cholangioscopy to guide the treatment. After the procedure, stone clearance and other safety measures will be assessed. Participants will be monitored during and after the procedure for any adverse events or complications. Approximately 30 days post-procedure, researchers will contact participants to document symptoms or side effects and assess symptom resolution. The main outcome measured is complete stone clearance immediately after the procedure, along with other secondary outcomes such as procedure time, number of procedures, and hospital stay length. This follow-up aims to ensure safety and evaluate the effectiveness of the treatments over time.

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