A Combined Endoscopy and Radiology-guided Radiofrequency Ablation Therapy Protocol for Inoperable Perihilar Cholangiocarcinoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Technical success of ERCP procedure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
COMBO-RFA Arm
Patients randomized to this arm will undergo same-session endoluminal radiofrequency ablation followed by biliary stenting
Intervention: Endoluminal radiofrequency ablation (Procedure)
COMBO-RFA Arm
Patients randomized to this arm will undergo same-session endoluminal radiofrequency ablation followed by biliary stenting
Intervention: Endoscopic biliary stenting (Procedure)
Endoscopic Drainage Arm
Patients randomized to this arm will undergo biliary stenting only
Intervention: Endoscopic biliary stenting (Procedure)
Outcomes
Primary Outcomes
Technical success of ERCP procedure
Time Frame: 2 months
Ability to correctly apply radiofrequency ablation and place stents in all the biliary ducts accessed on ERCP
Tumor response
Time Frame: 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 Outcomes
- Rate of procedure-related adverse events(12 months)
- Overall survival(12 months)
- Tumor microenvironment alterations(2 months)
Investigators
dr. Theodor Alexandru Voiosu
Gastroenterology Consultant
Clinical Hospital Colentina