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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

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
NameTimeMethod
Survival in both groups6 weeks
Secondary Outcome Measures
NameTimeMethod
Decompensation in both groups in the form of ascites or Hepatic Encephalopathy6 weeks
Worsening of liver severity score in both groups.6 weeks
Rebleeding in both groups6 weeks
Adverse events in both groups6 weeks
Re-bleeding in both groups for 5 days from end of therapy5 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

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