Clinical trial · Interventional
Endoluminal Radiofrequency Ablation for the Treatment of Malignant Biliary Stenosis
Endoluminal Radiofrequency Ablation of Tumors Affecting the Bile Ducts
NCT04801719CI-TRIAL-00050702completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The rationale of the study is to explore the safety and efficacy of endoluminal radiofrequency ablation prior metal stent insertion in patiens with malignant biliary stenosis.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
| Brachytherapy | — | UNRESOLVED | — |
| Radiofrequency Ablation | — | UNRESOLVED | — |
| Stent Complication | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Habib™ EndoHPB; Boston Scientific, US; former EMcision Ltd., UK | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental arm - endoluminal RFA
- description
- standard treatment protocol for malignant biliary stenosis + endoluminal RFA prior metal stent insertion
- interventionNames
- Device: Habib™ EndoHPB; Boston Scientific, US; former EMcision Ltd., UK
- type
- NO_INTERVENTION
- label
- Control arm
- description
- standard treatment protocol for malignant biliary stenosis which includes metal stent insertion
Primary outcomes (2)
- measure
- Stent patency
- timeFrame
- up to month 36 or death of the patient
- description
- Analysis of metal stent patency since insertion in both study arms (measured in months, Kaplan-Meier estimate).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically verified malignant stenosis of bile ducts * indication of implantation of SEMS by multidisciplinary indication committee * signed informed consent Exclusion Criteria: * life expectancy of less than 3 months * Karnofsky performance status of \<80% * history or concomitant treatment with intraarterial oncologic therapies (eg, hepatic arterial infusion, chemoembolization) * ongoing infections resistant to antibiotic therapy * clinical or biochemical signs of liver or renal failure * INR ≥ 1.3, serum albumin ≤ 35 g/l, haemoglobin ≤ 100 g/l, serum creatinine ≥ 200μmol/l
References
Publications (0)
Data not yet available
No reference posted for this study.