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

Sponsor

Clinical Hospital Colentina (Other)

Overall Status

Recruiting

CT.gov ID

NCT05563870

Collaborator

Carol Davila University of Medicine and Pharmacy (Other), Universitatea din Bucuresti (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Perihilar Cholangiocarcinoma	Procedure: Endoluminal radiofrequency ablation Procedure: Endoscopic biliary stenting	N/A

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.

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Endoscopic Drainage Arm Patients randomized to this arm will undergo biliary stenting only	Procedure: Endoscopic biliary stenting Endoscopic biliary stenting will be performed via ERCP using multiple plastic stents, in order to ensure propper drainage of all accessed hepatic territories.
Experimental: COMBO-RFA Arm Patients randomized to this arm will undergo same-session endoluminal radiofrequency ablation followed by biliary stenting	Procedure: Endoluminal radiofrequency ablation Endoluminal Radiofrequency ablation (RFA) of the entire stricture length will be performed using the Habib probe. A current of 7W will be delivered for 90s intervals at a time. If multiple ablation sessions are needed in order to ablate the entire stricture lenght, there will be an overlap of ablated areas in order to ensure proper stricture treatment. Dilation of the stricture prior to RFA delivery will be performed if required. After RFA treatment, biliary drainage of all hepatic territories will be ensured. Procedure: Endoscopic biliary stenting Endoscopic biliary stenting will be performed via ERCP using multiple plastic stents, in order to ensure propper drainage of all accessed hepatic territories.

Arm

Intervention/Treatment

Active Comparator: Endoscopic Drainage Arm

Patients randomized to this arm will undergo biliary stenting only

Procedure: Endoscopic biliary stenting

Endoscopic biliary stenting will be performed via ERCP using multiple plastic stents, in order to ensure propper drainage of all accessed hepatic territories.

Experimental: COMBO-RFA Arm

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

Procedure: Endoluminal radiofrequency ablation

Endoluminal Radiofrequency ablation (RFA) of the entire stricture length will be performed using the Habib probe. A current of 7W will be delivered for 90s intervals at a time. If multiple ablation sessions are needed in order to ablate the entire stricture lenght, there will be an overlap of ablated areas in order to ensure proper stricture treatment. Dilation of the stricture prior to RFA delivery will be performed if required. After RFA treatment, biliary drainage of all hepatic territories will be ensured.

Procedure: Endoscopic biliary stenting

Endoscopic biliary stenting will be performed via ERCP using multiple plastic stents, in order to ensure propper drainage of all accessed hepatic territories.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gastroenterology Department, Colentina Hospital	Bucharest		Romania	020125

Sponsors and Collaborators

Clinical Hospital Colentina
Carol Davila University of Medicine and Pharmacy
Universitatea din Bucuresti

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

dr. Theodor Alexandru Voiosu, Gastroenterology Consultant, Clinical Hospital Colentina

ClinicalTrials.gov Identifier:

NCT05563870

Other Study ID Numbers:

COMBO-RFA

First Posted:

Oct 3, 2022

Last Update Posted:

Jan 27, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by dr. Theodor Alexandru Voiosu, Gastroenterology Consultant, Clinical Hospital Colentina

perihilar cholangiocarcinoma

ERCP

Radiofrequency ablation

Additional relevant MeSH terms:

Cholangiocarcinoma

Klatskin Tumor

Study Results

No Results Posted as of Jan 27, 2023