ASGE guideline on the role of endoscopy in the evaluation and management of choledocholithiasis.
ASGE Standards of Practice Committee, James L Buxbaum, Syed M Abbas Fehmi...
https://pubmed.ncbi.nlm.nih.gov/30979521Actively Recruiting
Phase 4
Age: 19Years - 85Years
All Genders
ID07418112
Comparing the Efficacy and Safety of Holmium Laser Lithotripsy Versus Electrohydraulic Lithotripsy for Difficult Bile Duct and Pancreatic Duct Stones: A Randomized Controlled Trial
Led by Rush University Medical Center · Updated on 2026-02-18
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of a low-power holmium laser to treat large and/or 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.
CONDITIONS
Brief Title
Comparing the Efficacy and Safety of Holmium Laser Lithotripsy Versus Electrohydraulic Lithotripsy for the Treatment of Difficult Choledocholithiasis and Pancreatic Duct Stones
Who Can Participate
Age: 19Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 19 and 85 years
- Signed written informed consent
- Presence of one or more difficult biliary or pancreatic duct stones defined by at least one of: stone diameter 15 mm or more, impacted stone not removable with standard balloon or basket, stone located above a benign duct stricture, or failed prior ERCP stone extraction attempt
You will not qualify if you...
- Pregnancy
- Clinically significant uncorrectable coagulopathy (INR > 1.5 or platelet count < 50,000/µL)
- Surgically altered upper gastrointestinal anatomy preventing ERCP access unless alternative access is planned
- Known or suspected malignant biliary or pancreatic stricture with the stone
- Acute pancreatitis at screening unless gallstone pancreatitis with ongoing biliary obstruction
- Severe cardiopulmonary disease or other conditions making prolonged endoscopic procedure unsafe
- Life expectancy less than 6 months
- Inability or unwillingness to comply with study procedures or follow-up requirements
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Single procedure visit
Participants undergo an ERCP procedure where they receive either low-wattage holmium laser lithotripsy or electrohydraulic lithotripsy to break down large or difficult bile duct or pancreatic duct stones.
1 procedure visit (in-person)
Follow-up
Duration - About 30 days
Participants are monitored for adverse events and symptom resolution approximately 30 days after the procedure via phone call.
1 follow-up phone call
Trial Site Locations
Total: 1 location
1
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
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Research Team
N
Neal A Mehta, MD
A
Amanda Lin, DSc, CCRC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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