Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma
NCT05546372 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98
Last updated 2022-10-27
Summary
A multicentre, parallel group, open label, randomized controlled trial comparing endobiliary RFA prior to metal stent placement with stent placement only in patients with inoperable perihilar cholangiocarcinoma.
Conditions
- Perihilar Cholangiocarcinoma
Interventions
- DEVICE
-
Endobiliary radiofrequency ablation (eRFA)
Intraductal radiofrequency ablation of tumor prior to stent placement
- DEVICE
-
uncovered self-expanding metal stent (uSEMS)
Intraductal placement of uncovered metal stent
Sponsors & Collaborators
-
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-09
- Primary Completion
- 2026-03-31
- Completion
- 2026-03-31
Countries
- Netherlands
Study Locations
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