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ERCP With and Without EUS Guided HGS for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction

RecruitingNAAges 18 Years - anyAllMansoura University
NCT06613945 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

A prospective randomized clinical trial to evaluate efficacy and safety of combined EUS-HGS and ERCP compared to ERCP for bilateral biliary decompression in advanced malignant hilar biliary obstruction. The primary outcome will be technical success, clinical success, procedural duration, and re-interventions. Secondary outcomes will be the rate of adverse events. patients will be followed up at 1 and 3 month intervals

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📋 Eligibility rules (as published)
Inclusion Criteria: * Presence of inoperable malignant hilar biliary obstruction on magnetic resonance cholangiography, computed tomography and/or direct cholangiography bismuth type III \& IV only. * Histologically confirmed malignant hilar biliary obstruction. * Elevated serum bilirubin at least 3 times above the upper limit of normal (1.2 mg/dL). * Absence of duodenal narrowing/obstruction. * Accept sharing in the study Exclusion Criteria: * Pregnancy. * Distal biliary obstruction as the main lesion. * Benign biliary stenosis. * Malignant hilar biliary obstruction bismuth type I and II. * Presence of duodenal obstruction. * Surgically altered anatomy or inability to access the major duodenal papilla. * Patients underwent previous intervention for biliary drainage. * Previously failed biliary cannulation at ERCP. * Large volume ascites. * Patients unfit for anesthesia. * Patients having uncorrectable coagulopathy or thrombocytopenia. * History of allergy to radiocontrast agents. * Refuse sharing in the study.
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What it tests

  • ERCP biliary drainage
  • Combined ERCP and EUS-HGS biliary drainage
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Where

1 site
Mansoura univeristy
Al Mansurah, Egypt
🤝 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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