Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

122 Participants
are divided into 2 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