Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06175845

Endoscopic Radiofrequency Ablation for Unresectable Cholangiocarcinoma

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).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Cholangiocarcinoma Adenocarcinoma Bile Duct Cancer Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Bites and Stings Carcinoma Chemically-Induced Disorders Cholangitis Digestive System Diseases Digestive System Neoplasms Klatskin Tumor Liver Cancer Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Poisoning Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraductal biliary radiofrequency ablation

Procedure

Radiofrequency ablation via catheter and transpapillary access of malignant bile duct obstruction

Other names: RFA

Primary outcomes

  1. 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

  1. Overall survival

    Time frame: up to 30 month

    Time to death or last seen alive

  2. Satisfaction assessed by EORTC QLQ-C30 questionnaire

    Time frame: 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.

  3. Satisfaction assessed by EORTC QLQ-BIL21 questionnaire

    Time frame: 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.

  4. Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE V5

    Time frame: 6 months

    Safety events

  5. Clinical event rate at 6 months

    Time frame: 6 months

    Rate of clinical events defined as per primary outcome after 6 months follow up

  6. Total days of overnight-hospital-stays

    Time frame: 6 months

    Total days of overnight-hospital-stays

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Radiofrequency Ablation Via Catheter and Transpapillary Access in Patients With Cholangiocarcinoma

Acronym: ACTICCA-2

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2023
Registry last updated
Dec 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.