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Endoscopic Ultrasound-guided Rendezvous Versus Precut Papillotomy

RecruitingNAAges 18 Years - anyAllChinese University of Hong Kong
NCT06010576 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Selective bile duct cannulation is the most important step in endoscopic retrograde cholangiopancreatography (ERCP) for treatment of benign and malignant pancreatobiliary diseases, but it may fail in up to 15% of cases. Precut papillotomy is an advanced ERCP cannulation technique recommended by guidelines for rescue of difficult biliary access, but it is not without limitations. Endoscopic ultrasound (EUS)-guided biliary drainage is a novel interventional EUS technique that has been increasingly performed after failed biliary access by advanced ERCP cannulation techniques.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients age 18 years or older undergoing ERCP with indication for bile duct cannulation * Native major papilla * Difficult bile duct cannulation, defined by the presence of 1 of the following: 1) unsuccessful bile duct cannulation within 10 cannulation attempts, 2) unsuccessful bile duct cannulation within 10 minutes spent in cannulation, or 3) 2 unintended pancreatic duct cannulation or opacification with contrast * Written informed consent available Exclusion Criteria: * Unable to provide written informed consent * Contraindications for endoscopy due to comorbidities * Prior biliary sphincterotomy * Surgically altered upper gastrointestinal anatomy or duodenal obstruction precluding a standard ERCP * Uncorrectable coagulopathy (INR \> 1.5) and thrombocytopenia (platelet \< 50,000) by blood product transfusion * Pregnant patients
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What it tests

  • EUS-guided rendezvous
  • Early precut papillotomy group
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Where

1 site
Prince of Wales Hospital, The Chinese University of Hong Kong
Shatin, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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