Endoscopic Radiofrequency Ablation for Unresectable Cholangiocarcinoma

Not Applicable

Not yet recruiting

• Conditions: Klatskin Tumor; Bile Duct Cancer; Liver Cancer; Cholangiocarcinoma
• Interventions: Procedure: Intraductal biliary radiofrequency ablation

• Registration Number: NCT06175845
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-25
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-08
• Last Update Submitted: 2023-12-08
• Study First Posted: 2023-12-19
• Last Update Posted: 2023-12-19
• Study Start: 2024-02
• Primary Completion: 2026-01
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: ablation arm	Intraductal biliary radiofrequency ablation	Systemic chemotherapy and bile duct stenting with intraductal RFA of malignant bile duct obstructions employing a CE-certified ablation catheter prior to stent placement.

Primary Outcome Measures

Name	Time	Method
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 \[ERC\].)

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE V5	6 months	Safety events
Overall survival	up to 30 month	Time to death or last seen alive
Satisfaction assessed by EORTC QLQ-BIL21 questionnaire	6 months	The EORTC QLQ-BIL21 consists of 21 questions: 3 single-item assessments relating to treatment side effects, difficulties with drainage bags/tubes and concerns regarding weight loss, in addition to 18 items grouped into 5 proposed scales: eating symptoms (4 items), jaundice symptoms (3 items), tiredness (3 items), pain symptoms (4 items) and anxiety symptoms (4 items). The response format is a four-point Likert scale.and designed to more specifically adress side effects.; A high scale score represents a higher response level.
Clinical event rate at 6 months	6 months	Rate of clinical events defined as per primary outcome after 6 months follow up
Total days of overnight-hospital-stays	6 months	Total days of overnight-hospital-stays
Satisfaction assessed by EORTC QLQ-C30 questionnaire	6 months	The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in cancer patients. It is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.; Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany