Status:
UNKNOWN
Efficacy and Safety of Early TIPS (Transjugular Intrahepatic Portosystemic Shunts) in the Management of Cirrhosis With Recurrent Ascites.
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Liver Cirrhoses
Eligibility:
All Genders
18-60 years
Phase:
NA
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 c...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04013074
Start Date
July 9 2019
End Date
July 31 2020
Last Update
August 28 2019
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070