Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma

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

• Erasmus Medical Center

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• St. Antonius Hospital

  collaborator OTHER

• Medisch Spectrum Twente

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Clinical Hospital Colentina

  collaborator OTHER

• University Hospital Prague (IKEM), Prague, Czech Republic

  collaborator UNKNOWN

• Orlando Health, Inc.

  collaborator OTHER

• University Hospital, Ghent

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• 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

2022-10-22

Primary Completion

2027-06-30

Completion

2027-06-30

Countries

• Netherlands

Study Locations