NCT04013074

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cirrhoses

Interventions

Type	Name	Description
PROCEDURE	Transjugular Intrahepatic Portosystemic Shunt	Transjugular Intrahepatic Portosystemic Shunt
OTHER	Standard 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.

Timeline

• Start date: 2019-07-09
• Primary completion: 2020-07-31
• Completion: 2020-07-31
• First posted: 2019-07-09
• Last updated: 2019-08-28

Locations

1 site across 1 country: India