Effectiveness of invasive procedure in patient with liver disease
- Conditions
- Health Condition 1: K746- Other and unspecified cirrhosis ofliver
- Registration Number
- CTRI/2019/07/020246
- Lead Sponsor
- Institute of Liver and Biliary Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1) Liver Cirrhotics between 18-60 yrs of age (cirrhosis diagnosed on the basis of clinical, biochemical, fibroscan & imaging)
2) Recurrent ascites (2 or more large volume paracentesis in last 3 month) on maximal tolerated diuretic dose.
3) Diuretic intractable ascites (developing AKI/ hyponatremia (Na- <130 , hypo/ hyperkalemia ( <3.5 , >5.5), who will respond to withdrawal of diuretics
4) Hepatic Venous Pressure Gradient >12 mm Hg
5) CTP >= 7-12
6) Patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing.
1) Hepatic or extra hepatic Malignancy-HCC, PVT
2) MELD (Model for End Stage Liver Disease) > 18
3) Post TIPS (Transjugular Intrahepatic Portosystemic Shunt), Shunt surgery.
4) LVP (Large Volume Paracentesis) >3/month
5) Acute kidney injury (Sr.Cr >2mg/dl)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Transplant free survival in both groupsTimepoint: 1 year
- Secondary Outcome Measures
Name Time Method Incidence of Bleeding in both groupsTimepoint: 1 year;Incidence of Hepatic Encephalopathy in both groupsTimepoint: 1 year;Incidence of Acute Kidney Injury new complications in both groupsTimepoint: 1 year;Incidence of hyponatremia in both groupsTimepoint: 1 year;Incidence of Spontaneous bacterial Peritonitis in both groupsTimepoint: 1 year;Overall survival in both groupsTimepoint: 1 year;Reduction in HVPG from baseline in both groupsTimepoint: 6 and 12 month