Endoscopy and Radiology-guided Ablation for Inoperable Cholangiocarcinoma

Not Applicable

Active, not recruiting

• Conditions: Perihilar Cholangiocarcinoma
• Interventions: Procedure: Endoscopic biliary stenting; Procedure: Endoluminal radiofrequency ablation

• Registration Number: NCT05563870
• Lead Sponsor: Clinical Hospital Colentina

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-29
• Study First Posted: 2022-10-03
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic Drainage Arm	Endoscopic biliary stenting	Patients randomized to this arm will undergo biliary stenting only
COMBO-RFA Arm	Endoluminal radiofrequency ablation	Patients randomized to this arm will undergo same-session endoluminal radiofrequency ablation followed by biliary stenting
COMBO-RFA Arm	Endoscopic biliary stenting	Patients randomized to this arm will undergo same-session endoluminal radiofrequency ablation followed by biliary stenting

Primary Outcome Measures

Name	Time	Method
Technical success of ERCP procedure	2 months	Ability to correctly apply radiofrequency ablation and place stents in all the biliary ducts accessed on ERCP
Tumor response	6 months	To evaluate the efficacy of radiofrequency ablation in local disease control by assessing tumor response according to RECIST criteria at 6 months follow-up

Secondary Outcome Measures

Name	Time	Method
Rate of procedure-related adverse events	12 months	To evaluate the safety profile of the procedure by assessing the rate of procedure-related adverse events according to the ASGE lexicon (cholangitis, bleeding, perforation, pancreatitis) after endoscopic treatment
Overall survival	12 months	To assess patient survival rates at 12 months follow-up
Tumor microenvironment alterations	2 months	To evaluate the expression of programmed death (PD)-1 / PD- ligand 1 markers on biopsy samples of tumor tissue obtained at the index and follow-up ERCP procedure

Trial Locations

Locations (1)

Gastroenterology Department, Colentina Hospital; 🇷🇴 Bucharest, Romania