Endoscopy and Radiology-guided Ablation for Inoperable Cholangiocarcinoma — COMBO-RFA  

Perihilar Cholangiocarcinoma Clinical Trial

Official title: A Combined Endoscopy and Radiology-guided Radiofrequency Ablation Therapy Protocol for Inoperable Perihilar Cholangiocarcinoma

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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.

Patients presenting with jaundice / biliary obstruction caused by inoperable perihilar cholangiocarcinoma as assessed during multidisciplinary case discussion will be invited to enroll in this trial.

Patients will be randomized in a 1:1 fashion to receive biliary plastic stenting (control arm) or biliary plastic stenting + radiofrequency ablation via endoscopic approach. In cases where ERCP fails to achieve adequate biliary drainage, stenting and/or drainage will be attempted via percutaneous approach.

Additional systemic chemotherapy will be offered to all eligible patients according to the local standard of care.

Patients will be followed up with a clinical visit at 2 weeks and stent exchange (+ additional RFA treatment in the control arm) will be offered at 8-12 weeks interval until disease progression, clinical deterioration precluding ERCP or death.

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 ;

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Klatskin Tumor
• Perihilar Cholangiocarcinoma

• NCT number: NCT05563870
• Study type: Interventional
• Source: Clinical Hospital Colentina
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2022
• Completion date: December 31, 2024