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Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma

RecruitingNAAges 18 Years - anyAllAcademisch Medisch Centrum - Universiteit van Ams…
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In plain words

What the trial is, and whether it could suit you

A multicentre, parallel group, open label, randomized controlled trial comparing endobiliary RFA prior to metal stent placement with stent placement only in patients with inoperable perihilar cholangiocarcinoma.

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

📋 Eligibility rules (as published)
Inclusion Criteria: * 18 years or older. * Capable of providing written and oral informed consent. * Histological or cytological proof of perihilar CCA (adenocarcinoma). * Perihilar biliary obstruction with an indication for drainage with uSEMS.\* * Advanced (no candidate for surgical resection) due to metastases, vascular or lymph node (N2) involvement on imaging or during staging laparoscopy according to multidisciplinary team (MDT). * Only patients with pCCA are eligible however in case of reasonable doubt between intrahepatic CCA with a perihilar biliary obstruction or massforming pCCA, patients can be included. Exclusion Criteria: * Patients who potentially qualify for curative resection of pCCA. * pCCA eligible for liver transplantation. * Life-expectancy less than 3 months. * ERCP and PTC technically not feasible. * Uncontrolled coagulopathy (PTT \>1,5x prolonged or thrombocytes below 40\*10E9/L). * Ongoing cholangitis or liver abscess. Patients are required to be off antibiotic treatment for cholangitis and/or liver abscess at least 7 days. * Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study. * Patients who are pregnant or breastfeeding.
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What it tests

  • Endobiliary radiofrequency ablation (eRFA)
  • uncovered self-expanding metal stent (uSEMS)
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Where

1 site
Amsterdam UMC location VUmc
Amsterdam, Netherlands
🤝 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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