Endoluminal Radiofrequency Ablation of Tumors Affecting the Bile Ducts
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 76
- Locations
- 2
- Primary Endpoint
- Stent patency
Study Overview
Brief Summary
The rationale of the study is to explore the safety and efficacy of endoluminal radiofrequency ablation prior metal stent insertion in patiens with malignant biliary stenosis.
Detailed Description
The aim of this randomized study was to analyze survival rate in patients with malignant biliary obstruction treated with metal stent insertion with or without previous endoluminal radiofrequency ablation (RFA). Secondary endpoint was to analyze metal stent patency rate and survival rate in the subgroup of infiltrative hilar cholangiocarcinomas standardly treated by brachytherapy and metal stenting.
All patients underwent percutaneous cholangiography followed by transhepatic drainage, all patients underwent histopathologic verification of the stenosis.
Randomised patients in selected arm received endoluminal RFA by 8F catheter (Habib™ EndoHPB; EMcision Ltd., London, UK) before stenting procedure. Repeated ablations were processed through stenotic areas (10W, 90-120s, Rita 1500, Angiodynamics Ltd), all drained biliary tracts were used for introducing catheter and performance of ablation.
In experimental group ablation procedure was followed with uncovered self-expandable metal stent insertion.
Brachytherapy procedure (performed in case of cholangiocarcinoma as institutional treatment standard) was performed through 5F applicator by after loading system of iridium radiation source (HDR brachytherapy, applicator temporarily placed into a drain for 3-4 days). Prescribed dose was 15-24Gy at distance of 1.0cm in 3-4 fractions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •histologically verified malignant stenosis of bile ducts
- •indication of implantation of SEMS by multidisciplinary indication committee
- •signed informed consent
Exclusion Criteria
- •life expectancy of less than 3 months
- •Karnofsky performance status of <80%
- •history or concomitant treatment with intraarterial oncologic therapies (eg, hepatic arterial infusion, chemoembolization)
- •ongoing infections resistant to antibiotic therapy
- •clinical or biochemical signs of liver or renal failure
- •INR ≥ 1.3, serum albumin ≤ 35 g/l, haemoglobin ≤ 100 g/l, serum creatinine ≥ 200μmol/l
Outcomes
Primary Outcomes
Stent patency
Time Frame: up to month 36 or death of the patient
Analysis of metal stent patency since insertion in both study arms (measured in months, Kaplan-Meier estimate).
Overall survival
Time Frame: up to month 36 or death of the patient
Analysis of overall survival since the diagnosis, initial drainage, and metal stent insertion in both study arms (measured in months, Kaplan-Meier estimate).
Secondary Outcomes
- Complications of endoluminal RFA of biliary tract(up to day 30)
Investigators
Tomas Andrasina
Tomáš Andrašina, MD, PhD; Assistant professor, Head of Non-vascular interventions and Computed Tomography of the Department of Radiology and Nuclear Medicine
Brno University Hospital