Surgical procedure for the Management of Bleed in Liver Liver Disease.

Recruiting

• Conditions: Other and unspecified cirrhosis ofliver,

• Registration Number: CTRI/2019/06/019621
• Lead Sponsor: Institute of Liver and Biliary Sciences

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 Start: 2019-06-20
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: Open to Recruitment
• 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 2.
• Coagulopathy related bleed 3.
• Bleeding from Gastric varices 4.
• Any malignancy including HCC 5.
• Main Portal vein thrombosis 6.
• Patients in refractory shock 7.
• Patients with severe cardiopulmonary disease 8.
• Grade 4 Hepatic encephalopathy 9.
• MELD > 25 10.Multiorgan failure 11.Active sepsis 12.Pregnancy 13.
• Failure to give consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival in both groups	6 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Liver and Biliary Science; 🇮🇳 South, DELHI, India

Institute of Liver and Biliary Science

🇮🇳South, DELHI, India

Dr Shushrut Singh

Principal investigator

01146300000

drsushrut20@gmail.com