Endoscopy and Radiology-guided Ablation for Inoperable Cholangiocarcinoma (COMBO-RFA)

Clinical Hospital Colentina

Status: Active, not recruiting

Conditions: Perihilar Cholangiocarcinoma

Treatments: Procedure: Endoluminal radiofrequency ablation; Procedure: Endoscopic biliary stenting

Study type: Interventional

Funder types: Other

Identifiers

NCT05563870

COMBO-RFA

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Endoscopic Drainage Arm

Active Comparator group

Description:

Patients randomized to this arm will undergo biliary stenting only

Treatment:

Procedure: Endoscopic biliary stenting

COMBO-RFA Arm

Experimental group

Description:

Patients randomized to this arm will undergo same-session endoluminal radiofrequency ablation followed by biliary stenting

Treatment:

Procedure: Endoscopic biliary stenting

Procedure: Endoluminal radiofrequency ablation