Efficacy and Safety of Early TIPS (Transjugular Intrahepatic Portosystemic Shunts) in the Management of Cirrhosis With Recurrent Ascites.

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Early TIPS (Transjugular Intrahepatic Portosystemic Shunts) in the Management of Cirrhosis With Recurrent Ascites.

Conditions
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Liver Cirrhoses

Intervention / Treatment
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* Procedure: Transjugular Intrahepatic Portosystemic Shunt
* Other: Standard Medical Treatment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIPS+Standard Medical Treatment<br>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. | Procedure: Transjugular Intrahepatic Portosystemic Shunt<br>* Transjugular Intrahepatic Portosystemic Shunt<br>Other: Standard Medical Treatment<br>* 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.<br>|
| Active Comparator: Standard Medical Treatment<br>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. | Other: Standard Medical Treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transplant free survival in both groups |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival in both groups |  | 1 year | 
| Reduction in HVPG from baseline in both groups |  | 6 month | 
| Reduction in HVPG from baseline in both groups |  | 12 month | 
| Incidence of Acute Kidney Injury new complications in both groups |  | 1 year | 
| Incidence of Spontaneous bacterial Peritonitis in both groups |  | 1 year | 
| Incidence of Hepatic Encephalopathy in both groups |  | 1 year | 
| Incidence of Bleeding in both groups |  | 1 year | 
| Incidence of hyponatremia in both groups |  | 1 year |