Endoscopy and Radiology-guided Ablation for Inoperable Cholangiocarcinoma

Perihilar Cholangiocarcinoma Clinical Trial

— COMBO-RFA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05563870
• Other study ID #: COMBO-RFA
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Clinical Hospital Colentina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Klatskin Tumor
• Perihilar Cholangiocarcinoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
Romania	Gastroenterology Department, Colentina Hospital	Bucharest

Sponsors (3)

Lead Sponsor	Collaborator
Clinical Hospital Colentina	Carol Davila University of Medicine and Pharmacy, Universitatea din Bucuresti

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success of ERCP procedure	Ability to correctly apply radiofrequency ablation and place stents in all the biliary ducts accessed on ERCP	2 months
Primary	Tumor response	To evaluate the efficacy of radiofrequency ablation in local disease control by assessing tumor response according to RECIST criteria at 6 months follow-up	6 months
Secondary	Rate of procedure-related adverse events	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	12 months
Secondary	Overall survival	To assess patient survival rates at 12 months follow-up	12 months
Secondary	Tumor microenvironment alterations	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	2 months