Status:
NOT_YET_RECRUITING
Endoscopic Radiofrequency Ablation for Unresectable Cholangiocarcinoma
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Cholangiocarcinoma
Klatskin Tumor
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Unresectable perihilar and/or ductal CCA with bile duct stenting and palliative systemic therapy as indicated by the local Multidisciplinary Team (MDT)
- Written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Age ≥18 years
- Eligibility for palliative systemic therapy based on clinical and laboratory parameters (except hyperbilirubinemia) as determined by the local MDT
- No prior radiofrequency ablation (RFA) for CCA
- 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)
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06175845
Start Date
February 1 2024
End Date
July 1 2026
Last Update
December 19 2023
Active Locations (1)
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1
University Medical Center Hamburg-Eppendorf
Hamburg, Germany