Clinical trial NCT06175845: Endoscopic Radiofrequency Ablation for Unresectable Cholangiocarcinoma
Official title: Radiofrequency Ablation Via Catheter and Transpapillary Access in Patients With Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cholangiocarcinoma
Klatskin Tumor
Bile Duct Cancer
Liver Cancer
Keywords: Radiofrequency ablation
Intraductal
Biliary
Endoscopic retrograde cholangiography
Transpapillary
Stent dysfunction
Cholangitis
Obstruction
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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 outcomes:
measure: Time to first event, ie stent dysfunction
timeFrame: 6 months
Secondary outcomes:
measure: Overall survival
timeFrame: up to 30 month
measure: Satisfaction assessed by EORTC QLQ-C30 questionnaire
timeFrame: 6 months
measure: Satisfaction assessed by EORTC QLQ-BIL21 questionnaire
timeFrame: 6 months
measure: Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE V5
timeFrame: 6 months
measure: Clinical event rate at 6 months
timeFrame: 6 months
measure: Total days of overnight-hospital-stays
timeFrame: 6 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Johann von Felden, MD
role: PRINCIPAL_INVESTIGATOR
References: