All consecutive patients with cirrhosis of liver who satisfy the criteria will be included and will be evaluated clinically along with all routine investigations and standard medical therapy will be continued among these patients. The patients between 18-60 yrs of age (cirrhosis diagnosed on the basis of clinical, biochemical, fibroscan \& imaging.) , with ascites and HVPG (Hepatic Venous Pressure Gradient) \>12, with 2 or more large volume paracentesis in last 3 month . CTP ≥ 7-13 will be considered for the study. At baseline, a complete history of the cause of cirrhosis of liver with clinical and physical examination, a record of demographic profile, standard of care biochemical investigations would be done. In this study patients who satisfy the inclusion and exclusion criteria as mentioned below will be enrolled to receive either standard medical therapy with Large volume paracentesis and albumin infusion or to be randomised to receive TIPS (Transjugular Intrahepatic Portosystemic Shunt). The patients in group A will be given standard medical therapy only included as per requirement nutritional therapy (high calorie intake- 2400 Kcal/ day) as and when required Large Volume Paracentesis (LVP) and albumin infusion and diuretics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Transjugular Intrahepatic Portosystemic Shunt
Standard Medical Therapy only included as per requirement nutritional therapy (high calorie intake- 2400 Kcal/ day) as and when required LVP and albumin infusion and diuretics.
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
RECRUITINGTransplant free survival in both groups
Time frame: 1 year
Overall survival in both groups
Time frame: 1 year
Reduction in HVPG from baseline in both groups
Time frame: 6 month
Reduction in HVPG from baseline in both groups
Time frame: 12 month
Incidence of Acute Kidney Injury new complications in both groups
Time frame: 1 year
Incidence of Spontaneous bacterial Peritonitis in both groups
Time frame: 1 year
Incidence of Hepatic Encephalopathy in both groups
Time frame: 1 year
Incidence of Bleeding in both groups
Time frame: 1 year
Incidence of hyponatremia in both groups
Time frame: 1 year
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