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

Institute of Liver and Biliary Sciences, India

Status: Unknown

Conditions: Liver Cirrhoses

Treatments: Procedure: Transjugular Intrahepatic Portosystemic Shunt; Other: Standard Medical Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04013074

ILBS-Cirrhosis-23

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

TIPS+Standard Medical Treatment

Experimental group

Description:

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.

Treatment:

Procedure: Transjugular Intrahepatic Portosystemic Shunt

Other: Standard Medical Treatment

Standard Medical Treatment

Active Comparator group

Description:

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.

Treatment:

Other: Standard Medical Treatment