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

Liver Cirrhoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04013074
• Other study ID #: ILBS-Cirrhosis-23
• Status: Recruiting
• Phase: N/A
• Start date: July 9, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: July 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Vinay Kumar, MD
• Phone: 01146300000
• Email: drvinaybr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ascites
• Fibrosis
• Liver Cirrhoses
• Liver Cirrhosis

Intervention

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.

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transplant free survival in both groups		1 year
Secondary	Overall survival in both groups		1 year
Secondary	Reduction in HVPG from baseline in both groups		6 month
Secondary	Reduction in HVPG from baseline in both groups		12 month
Secondary	Incidence of Acute Kidney Injury new complications in both groups		1 year
Secondary	Incidence of Spontaneous bacterial Peritonitis in both groups		1 year
Secondary	Incidence of Hepatic Encephalopathy in both groups		1 year
Secondary	Incidence of Bleeding in both groups		1 year
Secondary	Incidence of hyponatremia in both groups		1 year