Comparing the Efficacy and Safety of Holmium Laser Lithotripsy Versus Electrohydraulic Lithotripsy for the Treatment of Difficult Choledocholithiasis and Pancreatic Duct Stones (NCT07418112)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (9 items).
Location: Rush University Medical Center โ Chicago, Illinois
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Pregnancy: Repeated ERCP would be delayed until after delivery if possible
- Clinically significant, uncorrectable coagulopathy (defined as INR \> 1.5 or platelet count \< 50,000/ฮผL).
- Surgically altered upper gastrointestinal anatomy that precludes conventional ERCP access (e.g., Roux-en-Y gastric bypass), unless an alternative access route (e.g., laparoscopy-assisted or EUS-directed) is planned as the standard of care.
- Known or highly suspected malignant biliary or pancreatic stricture associated with the stone.
- Acute pancreatitis at the time of screening, unless it is gallstone pancreatitis with persistent biliary obstruction, for which ERCP is therapeutically indicated.
- Severe cardiopulmonary disease or other comorbidities that, in the judgment of the investigator, would make the patient an unsuitable candidate for a prolonged endoscopic procedure under general anesthesia.
- Known life expectancy of less than 6 months.
- Inability or unwillingness to comply with study procedures or follow-up requirements.
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (1 Sites)
- Rush University Medical Center โ Chicago, Illinois
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.