Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04013074
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

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.


Condition or disease Intervention/treatment Phase
Liver Cirrhoses Procedure: Transjugular Intrahepatic Portosystemic Shunt Other: Standard Medical Treatment Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Early TIPS (Transjugular Intrahepatic Portosystemic Shunts) in the Management of Cirrhosis With Recurrent Ascites.
Actual Study Start Date : July 9, 2019
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Transplant free survival in both groups [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Overall survival in both groups [ Time Frame: 1 year ]
  2. Reduction in HVPG from baseline in both groups [ Time Frame: 6 month ]
  3. Reduction in HVPG from baseline in both groups [ Time Frame: 12 month ]
  4. Incidence of Acute Kidney Injury new complications in both groups [ Time Frame: 1 year ]
  5. Incidence of Spontaneous bacterial Peritonitis in both groups [ Time Frame: 1 year ]
  6. Incidence of Hepatic Encephalopathy in both groups [ Time Frame: 1 year ]
  7. Incidence of Bleeding in both groups [ Time Frame: 1 year ]
  8. Incidence of hyponatremia in both groups [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04013074


Contacts
Layout table for location contacts
Contact: Dr Vinay Kumar, MD 01146300000 drvinaybr@gmail.com

Locations
Layout table for location information
India
Institute of Liver & Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Contact: Dr Vinay Kumar, MD    01146300000    drvinaybr@gmail.com   
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India

Layout table for additonal information
Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT04013074     History of Changes
Other Study ID Numbers: ILBS-Cirrhosis-23
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Cirrhosis
Fibrosis
Ascites
Pathologic Processes
Liver Diseases
Digestive System Diseases
Diuretics
Natriuretic Agents
Physiological Effects of Drugs