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.

• Status: Recruiting
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

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 at 6 week or Early re Bleed. All enrolled patients will also undergo HVPG measurement at baseline to stratify risk of failure to control bleed or early re-bleed.

Patient will be monitored for 5 days for re bleed, complications of therapy, worsening of Liver function tests and scores and efficacy of either treatment modality over other. Patient will be followed for 6 weeks to see for the primary end point.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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