NCT05546372 Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma
| NCT ID | NCT05546372 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Perihilar Cholangiocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 122 participants |
| Start Date | 2022-10-22 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 122 participants in total. It began in 2022-10-22 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05546372 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Perihilar Cholangiocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05546372 currently recruiting?
Yes, NCT05546372 is actively recruiting participants. Contact the research team at e.smit1@amsterdamumc.nl for enrollment information.
Where is the NCT05546372 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT05546372 clinical trial?
NCT05546372 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The trial plans to enroll 122 participants.