Status:
UNKNOWN
To Study the Efficacy and Safety of TIPS (Trans Intrahepatic Portosystemic Shunt) Versus Self Expanding Metallic Stent (SEMS) in the Management of Refractory Variceal Bleed in Cirrhotics.
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Liver Cirrhoses
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
A total of 50 patients will be enrolled and will be randomized into either Group A(TIPS) or Group B (SEMS). Primary end point of the study will be to compare efficacy of TIPS versus SEMS for survival...
Eligibility Criteria
Inclusion
- \- Consecutive patients of cirrhosis aged 18-70 years presenting with acute variceal Bleeding, who on endoscopy fail to control bleed or rebleeds within 5 days will be randomized.
Exclusion
- Bleeding from non-variceal source
- Coagulopathy related bleed
- Bleeding from Gastric varices
- Any malignancy including HCC
- Main Portal vein thrombosis
- Patients in refractory shock
- Patients with severe cardiopulmonary disease
- Grade 4 Hepatic encephalopathy
- MELD \> 25
- Multiorgan failure
- Active sepsis
- Pregnancy
- Failure to give consent
Key Trial Info
Start Date :
February 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03827681
Start Date
February 6 2019
End Date
June 30 2020
Last Update
March 10 2020
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070