Endoscopic Radiofrequency Ablation for Unresectable Cholangiocarcinoma

NCT06175845 · tracked via the Priya Life Science Germany tracker

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Phase

Not applicable

Started

2024-08-30

Last updated

2026-09-09

Condition(s) studied

CholangiocarcinomaKlatskin TumorBile Duct CancerLiver Cancer

Investigational drug(s) / intervention(s)

Intraductal biliary radiofrequency ablation

Intraductal biliary radiofrequency ablation: Radiofrequency ablation via catheter and transpapillary access of malignant bile duct obstruction

Study summary

The goal of this clinical trial is to learn about radiofrequency ablation in patients with unresectable bile duct cancer who receive systemic chemotherapy and bile duct stenting. The main questions it aims to answer are:

* Does radiofrequency ablation of tumorous bile duct occlusion reduce risk of complications in these patients (eg stent dysfunction, delay of chemotherapy, infections etc)?
* Is radiofrequency ablation safe in these patients? All participants will receive standard treatment with systemic chemotherapy and bile duct stenting. Researchers will compare two groups (one group will receive additional radiofrequency ablation, the other not).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Unresectable perihilar and/or ductal CCA with bile duct stenting and palliative systemic therapy as indicated by the local Multidisciplinary Team (MDT) 2. Written informed consent 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 4. Age ≥18 years 5. Eligibility for palliative systemic therapy based on clinical and laboratory parameters (except hyperbilirubinemia) as determined by the local MDT 6. No prior radiofrequency ablation (RFA) for CCA 7. No repeated bile duct stenting in the past 3 months (trial inclusion is possible upon first stent replacement or initial stent placement within past 3 months) 8. No concomitant disease or malignancy interfering with the study procedure or efficacy outcome measures, particularly no severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, myocardial infarction within ≤3 months, significant arrhythmias) and no psychiatric disorders precluding understanding of information of trial related topics and giving informed consent

Primary outcome measure(s)

Time to first event, ie stent dysfunction — 6 months
• Time-to-first event (during 6 months follow up), i.e. stent dysfunction defined by bilirubin \>5 mg/dl and/or cholangitis (fever \>38.5°C and/or increase in C-reactive protein by at least 3-fold upper limit of normal and at least 20% from baseline without extrahepatic focus and absence of tumor progression) leading to premature stent replacement and/or disruption of chemotherapy (all possible events will be reviewed by a blinded and independent Endpoint Review Committee \[ERC\].)

Trial sites (9)

Facility	City	Region	Status
Charite	Berlin	Germany	Recruiting
University Medical Center	Bonn	Germany	Recruiting
Clinic Chemnitz	Chemnitz	Germany	Recruiting
University Clinic	Essen	Germany	Recruiting
University Medical Center Hamburg-Eppendorf	Hamburg	Germany	Recruiting
Medical School Hannover	Hanover	Germany	Recruiting
University Clinic	Heidelberg	Germany	Recruiting
UKSH	Lübeck	Germany	Recruiting
Clinic Ulm	Ulm	Germany	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06175845 on ClinicalTrials.gov ↗ ← All trials in Germany