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.

Not Applicable

• Conditions: Liver Cirrhoses
• Interventions: Procedure: Self Expanding Metallic Stent; Procedure: Trans Intrahepatic Portosystemic Shunt; Drug: Vasoactive Agent

• Registration Number: NCT03827681
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-01
• Study Start: 2019-02-06
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIPS + Vasoactive Drug	Vasoactive Agent	-
SEMS + Vasoactive Drug	Self Expanding Metallic Stent	-
TIPS + Vasoactive Drug	Trans Intrahepatic Portosystemic Shunt	-
SEMS + Vasoactive Drug	Vasoactive Agent	-

Primary Outcome Measures

Name	Time	Method
Survival in both groups	6 weeks

Secondary Outcome Measures

Name	Time	Method
Worsening of liver severity score in both groups.	6 weeks
Re-bleeding in both groups for 5 days from end of therapy	5 days
Rebleeding in both groups	6 weeks
Decompensation in both groups in the form of ascites or Hepatic Encephalopathy	6 weeks
Adverse events in both groups	6 weeks

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, Delhi, India