search
Back to results

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

Primary Purpose

Liver Cirrhoses

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Transjugular Intrahepatic Portosystemic Shunt
Standard Medical Treatment
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhoses

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

  • Institute of Liver & Biliary SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TIPS+Standard Medical Treatment

Standard Medical Treatment

Arm 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.

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.

Outcomes

Primary Outcome Measures

Transplant free survival in both groups

Secondary Outcome Measures

Overall survival in both groups
Reduction in HVPG from baseline in both groups
Reduction in HVPG from baseline in both groups
Incidence of Acute Kidney Injury new complications in both groups
Incidence of Spontaneous bacterial Peritonitis in both groups
Incidence of Hepatic Encephalopathy in both groups
Incidence of Bleeding in both groups
Incidence of hyponatremia in both groups

Full Information

First Posted
July 7, 2019
Last Updated
August 26, 2019
Sponsor
Institute of Liver and Biliary Sciences, India
search

1. Study Identification

Unique Protocol Identification Number
NCT04013074
Brief Title
Efficacy and Safety of Early TIPS (Transjugular Intrahepatic Portosystemic Shunts) in the Management of Cirrhosis With Recurrent Ascites.
Official Title
Efficacy and Safety of Early TIPS (Transjugular Intrahepatic Portosystemic Shunts) in the Management of Cirrhosis With Recurrent Ascites.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 9, 2019 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhoses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TIPS+Standard Medical Treatment
Arm Type
Experimental
Arm 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.
Arm Title
Standard Medical Treatment
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Transjugular Intrahepatic Portosystemic Shunt
Intervention Description
Transjugular Intrahepatic Portosystemic Shunt
Intervention Type
Other
Intervention Name(s)
Standard Medical Treatment
Intervention 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.
Primary Outcome Measure Information:
Title
Transplant free survival in both groups
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall survival in both groups
Time Frame
1 year
Title
Reduction in HVPG from baseline in both groups
Time Frame
6 month
Title
Reduction in HVPG from baseline in both groups
Time Frame
12 month
Title
Incidence of Acute Kidney Injury new complications in both groups
Time Frame
1 year
Title
Incidence of Spontaneous bacterial Peritonitis in both groups
Time Frame
1 year
Title
Incidence of Hepatic Encephalopathy in both groups
Time Frame
1 year
Title
Incidence of Bleeding in both groups
Time Frame
1 year
Title
Incidence of hyponatremia in both groups
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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) 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Vinay Kumar, MD
Phone
01146300000
Email
drvinaybr@gmail.com
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Vinay Kumar, MD
Phone
01146300000
Email
drvinaybr@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs