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

RecruitingPhase 4Ages 19 Years - 85 YearsAllRush University Medical Center
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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 attempt using standard techniques (e.g., sphincterotomy with balloon/basket extraction). 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.
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What it tests

  • Laser lithotripsy with low-wattage holmium laser
  • Electrohydraulic lithotripsy
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Where

1 site
Rush University Medical Center
Chicago, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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