Efficacy and Safety of Early TIPS (Transjugular Intrahepatic Portosystemic Shunts) in the Management of Cirrhosis With Recurrent Ascites.
Liver Cirrhoses
About this trial
This is an interventional treatment trial for Liver Cirrhoses
Eligibility Criteria
Inclusion Criteria:
- Liver Cirrhotics between 18-60 yrs of age (cirrhosis diagnosed on the basis of clinical, biochemical, fibroscan & imaging)
- Recurrent ascites (2 or more large volume paracentesis in last 3 month) on maximal tolerated diuretic dose.
- Diuretic intractable ascites ( developing AKI/ hyponatremia (Na-<130 , hypo/ hyperkalemia (<3.5 , >5.5), who will respond to withdrawal of diuretics
- HVPG >12 mm Hg
- CTP ≥ 7-12
- Patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing.
Exclusion Criteria:
- Hepatic or extra hepatic Malignancy-HCC, PVT
- MELD (Model for End Stage Liver Disease) > 18
- Post TIPS (Transjugular Intrahepatic Portosystemic Shunt), Shunt surgery
- LVP (Large Volume Paracentesis) >3/month
- 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)
Sites / Locations
- Institute of Liver & Biliary SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
TIPS+Standard Medical Treatment
Standard Medical Treatment
TIPS along with 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.
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.