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Endoscopic Radiofrequency Ablation for Unresectable Cholangiocarcinoma

ConditionsCholangiocarcinomaKlatskin TumorBile Duct CancerLiver Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitätsklinikum Hamburg-Eppendorf

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intraductal biliary radiofrequency ablation

    Procedure/Surgery

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

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Arm A: ablation armActive comparator 1 intervention
Group B: Arm B: control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Time to first event, ie stent dysfunction

• 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 \[ERC\].)

Time frame
6 months

Secondary outcomes

1

Overall survival

Time to death or last seen alive

Time frame
up to 30 month
2

Satisfaction assessed by EORTC QLQ-C30 questionnaire

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.

Time frame
6 months
3

Satisfaction assessed by EORTC QLQ-BIL21 questionnaire

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.

Time frame
6 months
4

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

Safety events

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitätsklinikum Hamburg-Eppendorf

Lead sponsor

Source ClinicalTrials.gov
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