Status:
COMPLETED
Endoluminal Radiofrequency Ablation for the Treatment of Malignant Biliary Stenosis
Lead Sponsor:
Brno University Hospital
Conditions:
Radiofrequency Ablation
Biliary Tract Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 abla...
Eligibility Criteria
Inclusion
- histologically verified malignant stenosis of bile ducts
- indication of implantation of SEMS by multidisciplinary indication committee
- signed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
January 4 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04801719
Start Date
January 4 2010
End Date
December 31 2019
Last Update
March 17 2021
Active Locations (1)
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1
Brno University Hospital
Brno, Czechia, 62500