A Combined Endoscopy and Radiology-guided Radiofrequency Ablation Therapy Protocol for Inoperable Perihilar Cholangiocarcinoma (COMBO-RFA)

  • End date
    Dec 31, 2024
  • participants needed
  • sponsor
    Clinical Hospital Colentina
Updated on 20 October 2022


This prospective clinical trial aims to assess the feasibility, efficacy, and safety of a personalized radiofrequency ablation protocol coupled with complete biliary drainage for patients presenting with inoperable perihilar cholangiocarcinoma.


This clinical trial proposes a personalized treatment approach to inoperable perihilar cholangiocarcinoma consisting of endoluminal ablative therapy via radiofrequency ablation followed by endoscopic biliary drainage.

The main study objectives are:

  • To assess the technical feasibility of implementing the proposed therapeutic protocol involving a combined endoscopic-radiologic approach to drainage and ablation
  • To evaluate the efficacy of radiofrequency ablation in local disease control
  • To evaluate whether complete drainage and radiofrequency ablation have a cumulative benefit in patients with inoperable perihilar cholangiocarcinoma
  • To evaluate the safety of our proposed therapeutic protocol combining interventional endoscopy with radiology

Condition Perihilar Cholangiocarcinoma
Treatment Endoscopic Biliary Stenting, Endoluminal radiofrequency ablation
Clinical Study IdentifierNCT05563870
SponsorClinical Hospital Colentina
Last Modified on20 October 2022


Yes No Not Sure

Inclusion Criteria

perihilar cholangiocarcinoma
locally advanced disease (unresectable)
M1 (limted to 1 site)

Exclusion Criteria

refusal to sogn the ICF
poor performance status (ECOG >2)
surgically altered anatomy (i.e Bilroth II or Roux-en-Y interventions)
significant comorbidities
ASA score >3
life expectancy <3 months
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