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

NCT ID: NCT04013074

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-09
• Study Completion Date: 2020-07-31

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.

Conditions

Liver Cirrhoses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TIPS+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.

Group Type: EXPERIMENTAL

Transjugular Intrahepatic Portosystemic Shunt

Intervention Type: PROCEDURE

Transjugular Intrahepatic Portosystemic Shunt

Standard Medical Treatment

Intervention Type: OTHER

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 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.

Group Type: ACTIVE_COMPARATOR

Standard Medical Treatment

Intervention Type: OTHER

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.

Interventions

Transjugular Intrahepatic Portosystemic Shunt

Transjugular Intrahepatic Portosystemic Shunt

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status: RECRUITING

Countries

India

Central Contacts

Dr Vinay Kumar, MD

Role: CONTACT

drvinaybr@gmail.com

01146300000

Facility Contacts

Dr Vinay Kumar, MD

Role: primary

drvinaybr@gmail.com

01146300000

Other Identifiers

ILBS-Cirrhosis-23

Identifier Type: -

Identifier Source: org_study_id