Endoscopy and Radiology-guided Ablation for Inoperable Cholangiocarcinoma

Trial Title: Endoscopy and Radiology-guided Ablation for Inoperable Cholangiocarcinoma

NCT ID: NCT05563870

Condition: Perihilar Cholangiocarcinoma

Conditions: Official terms:
Cholangiocarcinoma
Klatskin Tumor

Conditions: Keywords:
perihilar cholangiocarcinoma
ERCP
Radiofrequency ablation

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: Endoluminal radiofrequency ablation
Description: 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.
Arm group label: COMBO-RFA Arm

Intervention type: Procedure
Intervention name: Endoscopic biliary stenting
Description: Endoscopic biliary stenting will be performed via ERCP using multiple plastic stents, in order to ensure propper drainage of all accessed hepatic territories.
Arm group label: COMBO-RFA Arm
Arm group label: Endoscopic Drainage Arm

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

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Gastroenterology Department, Colentina Hospital

Address:
City: Bucharest
Zip: 020125
Country: Romania

Start date: August 1, 2022

Completion date: December 31, 2024

Lead sponsor:
Agency: Clinical Hospital Colentina
Agency class: Other

Collaborator:
Agency: Carol Davila University of Medicine and Pharmacy
Agency class: Other

Collaborator:
Agency: Universitatea din Bucuresti
Agency class: Other

Source: Clinical Hospital Colentina

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05563870