An interventional study of Intraductal biliary radiofrequency ablation in Cholangiocarcinoma, Klatskin Tumor and Bile Duct Cancer, sponsored by Universitätsklinikum Hamburg-Eppendorf. Recruiting at 9 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Treatment
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:
82 studies on the registry are indexed under Klatskin Tumor; 27 are open to participants now.
This study's planned enrollment of 130 is above the median of 55 across 56 interventional studies indexed under Klatskin Tumor.
Browse Klatskin Tumor studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 416 studies on the registry; 86 are open to participants now.
Compared within Klatskin Tumor, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cholangiocarcinoma. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Systemic chemotherapy and bile duct stenting with intraductal RFA of malignant bile duct obstructions employing a CE-certified ablation catheter prior to stent placement.
Procedure: Intraductal biliary radiofrequency ablation
Systemic chemotherapy and bile duct stenting without RFA.
Radiofrequency ablation via catheter and transpapillary access of malignant bile duct obstruction
Also known as: RFA
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
Overall survival
Time to death or last seen alive
Time frame: up to 30 month
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
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
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE V5
Safety events
Time frame: 6 months
Clinical event rate at 6 months
Rate of clinical events defined as per primary outcome after 6 months follow up
Time frame: 6 months
Total days of overnight-hospital-stays
Total days of overnight-hospital-stays
Time frame: 6 months
Started Aug 2024 (actual). Primary completion is estimated for Jul 2027, 35 months after the start.
How these figures are worked out, and which studies are left out of them.
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