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Tests heat treatment inside bile ducts before stent placement for bile duct cancer

Tests heat ablation before a metal stent in adults with blocked bile ducts from cancer.

Plain-language title generated from the registry record
Registry title: Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma

Key facts

Where
Amsterdam, NetherlandsSee the site

Where in Netherlands

  • Amsterdam UMC location VUmcAmsterdam, NetherlandsTaking people

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Trial details

Who runs it
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Trial code
NCT05546372
Record updated
26 May 2026
Original description
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.Read full original descriptionShow less

Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma: a Randomized Controlled Trial

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.

Inclusion: 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: Patients who potentially qualify for curative resection of pCCA; pCCA eligible for liver transplantation; Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study; Uncontrolled coagulopathy (PTT >1,5x prolonged or thrombocytes below 40*10E9/L); Life-expectancy less than 3 months; ERCP and PTC technically not feasible; Ongoing cholangitis or liver abscess. Patients are required to be off antibiotic treatment for cholangitis and/or liver abscess at least 7 days; Patients who are pregnant or breastfeeding.

ClinicalTrials.gov NCT05546372