Clinical trial · Interventional
Endoscopic Radiofrequency Ablation for Unresectable Cholangiocarcinoma
Radiofrequency Ablation Via Catheter and Transpapillary Access in Patients With Cholangiocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Cancer | Malignant Bile Duct Neoplasm | CURATED_BROADER | 0.80 |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Klatskin Tumor | Hilar Cholangiocarcinoma | ALIAS | 0.90 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraductal biliary radiofrequency ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A: ablation arm
- description
- Systemic chemotherapy and bile duct stenting with intraductal RFA of malignant bile duct obstructions employing a CE-certified ablation catheter prior to stent placement.
- interventionNames
- Procedure: Intraductal biliary radiofrequency ablation
- type
- NO_INTERVENTION
- label
- Arm B: control arm
- description
- Systemic chemotherapy and bile duct stenting without RFA.
Primary outcomes (1)
- measure
- Time to first event, ie stent dysfunction
- timeFrame
- 6 months
- description
- • 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 \[ERC\].)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSchmidt C, Zapf A, Ozga AK, Canbay A, Denzer U, De Toni EN, Lohse AW, Schulze K, Rosch T, Stein A, Wege H, von Felden J. Radiofrequency ablation via catheter and transpapillary access in patients with cholangiocarcinoma (ACTICCA-2 trial) - a multicenter, randomized, controlled, open-label investigator-initiated trial. BMC Cancer. 2024 Aug 1;24(1):931. doi: 10.1186/s12885-024-12693-w. PMID 39090600