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.

Institute of Liver and Biliary Sciences, India

Status: Unknown

Conditions: Liver Cirrhoses

Treatments: Drug: Vasoactive Agent; Procedure: Trans Intrahepatic Portosystemic Shunt; Procedure: Self Expanding Metallic Stent

Study type: Interventional

Funder types: Other

Identifiers

NCT03827681

ILBS-Cirrhosis-20

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

TIPS + Vasoactive Drug

Experimental group

Treatment:

Drug: Vasoactive Agent

Procedure: Trans Intrahepatic Portosystemic Shunt

SEMS + Vasoactive Drug

Active Comparator group

Treatment:

Drug: Vasoactive Agent

Procedure: Self Expanding Metallic Stent