Liver Cirrhoses
Conditions
Brief summary
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.
Interventions
Transjugular Intrahepatic Portosystemic Shunt
OTHERStandard Medical Treatment
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.
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
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. HVPG \>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.
Exclusion criteria
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) 5\) CKD (Chronic Kidney Injury) 6) Previous hepatic encephalopathy 7) Acute on chronic liver failure 8) Active infection 9) Active alcohol intake 10) Left Ventricular systolic dysfunction/ overt CCM 11) PPH (Portopulmonary Hypertension) 12) Pt on mechanical ventilation 13) Patient in ICU/ any acute illness 14) Pregnant lady 15) SBP (Spontaneous bacterial Peritonitis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transplant free survival in both groups | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in HVPG from baseline in both groups | 6 month |
| Incidence of Acute Kidney Injury new complications in both groups | 1 year |
| Incidence of Spontaneous bacterial Peritonitis in both groups | 1 year |
| Overall survival in both groups | 1 year |
| Incidence of Bleeding in both groups | 1 year |
| Incidence of hyponatremia in both groups | 1 year |
| Incidence of Hepatic Encephalopathy in both groups | 1 year |
Countries
India
Contacts
Primary ContactDr Vinay Kumar, MD
Outcome results
None listed