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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: ablation arm | Active Comparator | Systemic chemotherapy and bile duct stenting with intraductal RFA of malignant bile duct obstructions employing a CE-certified ablation catheter prior to stent placement. |
|
| Arm B: control arm | No Intervention | Systemic chemotherapy and bile duct stenting without RFA. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraductal biliary radiofrequency ablation | Procedure | Radiofrequency ablation via catheter and transpapillary access of malignant bile duct obstruction |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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].) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Time to death or last seen alive | 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. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johann von Felden, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Hamburg | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39090600 | Derived | Schmidt C, Zapf A, Ozga AK, Canbay A, Denzer U, De Toni EN, Lohse AW, Schulze K, Rosch T, Stein A, Wege H, von Felden J. Radiofrequency ablation via catheter and transpapillary access in patients with cholangiocarcinoma (ACTICCA-2 trial) - a multicenter, randomized, controlled, open-label investigator-initiated trial. BMC Cancer. 2024 Aug 1;24(1):931. doi: 10.1186/s12885-024-12693-w. |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| D018285 | Klatskin Tumor |
| D001650 | Bile Duct Neoplasms |
| D008113 | Liver Neoplasms |
| D002761 | Cholangitis |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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|
| 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. | 6 months |
| Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE V5 | Safety events | 6 months |
| Clinical event rate at 6 months | Rate of clinical events defined as per primary outcome after 6 months follow up | 6 months |
| Total days of overnight-hospital-stays | Total days of overnight-hospital-stays | 6 months |
| D009369 | Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |