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

NCT04013074 | Unknown

• 1 other identifier: ILBS-Cirrhosis-23
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Transplant free survival in both groups

  1 year

Secondary Outcomes (8)

• 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

Study Arms (2)

TIPS+Standard Medical Treatment

EXPERIMENTAL

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; Other: Standard Medical Treatment

Standard Medical Treatment

ACTIVE COMPARATOR

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

Interventions

Transjugular Intrahepatic Portosystemic Shunt PROCEDURE

Transjugular Intrahepatic Portosystemic Shunt

TIPS+Standard Medical Treatment

Standard Medical Treatment 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; TIPS+Standard Medical Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• \) 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)

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Central Study Contacts

Dr Vinay Kumar, MD

CONTACT

01146300000; drvinaybr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2019
• First Posted: July 9, 2019
• Study Start: July 9, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: August 28, 2019

Record last verified: 2019-07

Locations

IN (1)