About this trial
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.
Eligibility criteria
Qualifiers
18 years or older.
Capable of providing written and oral informed consent.
Histological or cytological proof of perihilar CCA (adenocarcinoma).
Perihilar biliary obstruction with an indication for drainage with uSEMS.*
Disqualifiers
Patients who potentially qualify for curative resection of pCCA.
pCCA eligible for liver transplantation.
Life-expectancy less than 3 months.
ERCP and PTC technically not feasible.
Trial design
Treatments tested in this trial
- Endobiliary radiofrequency ablation (eRFA)
- uncovered self-expanding metal stent (uSEMS)
Treatment groups
Sponsors and collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Erasmus Medical Center
Collaborator
Leiden University Medical Center
Collaborator
UMC Utrecht
Collaborator
University Medical Center Groningen
Collaborator
St. Antonius Hospital
Collaborator
Medisch Spectrum Twente
Collaborator
Maastricht University Medical Center
Collaborator
Clinical Hospital Colentina
Collaborator
University Hospital Prague (IKEM), Prague, Czech Republic
Collaborator
Orlando Health, Inc.
Collaborator
University Hospital, Ghent
Collaborator
Universitaire Ziekenhuizen KU Leuven
Collaborator