NCT05546372Recruiting
Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma
Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma: a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 26 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 122 (estimated)
- First submitted
- 25 Aug 2022
- Start date
- 22 Oct 2022
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05546372
What you commit to
- Study type: Interventional
- Planned participants: 122
- From 22 Oct 2022 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who potentially qualify for curative resection of pCCA.
- pCCA eligible for liver transplantation.
Other illness
- Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study.
Lab values
- Uncontrolled coagulopathy (PTT \>1,5x prolonged or thrombocytes below 40\*10E9/L).
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC location VUmc Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.