Radiofrequency Ablation Via Catheter and Transpapillary Access in Patients With Cholangiocarcinoma

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country130 target enrollmentFebruary 2024

ConditionsCholangiocarcinoma Klatskin Tumor Bile Duct Cancer Liver Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cholangiocarcinoma
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Enrollment: 130
Locations: 1
Primary Endpoint: Time to first event, ie stent dysfunction
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 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).

Registry

clinicaltrials.gov

Start Date

February 2024

End Date

July 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Responsible Party

Principal Investigator

Johann von Felden

Principal Investigator

Universitätsklinikum Hamburg-Eppendorf

Eligibility Criteria

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 Criteria

Not provided

Outcomes

Primary Outcomes

Time to first event, ie stent dysfunction

Time Frame: 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 \[ERC\].)

Secondary Outcomes

Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE V5(6 months)
Overall survival(up to 30 month)
Satisfaction assessed by EORTC QLQ-BIL21 questionnaire(6 months)
Clinical event rate at 6 months(6 months)
Total days of overnight-hospital-stays(6 months)
Satisfaction assessed by EORTC QLQ-C30 questionnaire(6 months)