Efficacy and Safety of Early TIPS (Transjugular Intrahepatic Portosystemic Shunts) in the Management of Cirrhosis With Recurrent Ascites.
Transjugular Intrahepatic Portosystemic Shunt
+ Standard Medical Treatment
Treatment Study
Summary
Study start date: July 9, 2019
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Institute of Liver & Biliary Sciences
New Delhi, IndiaOpen Institute of Liver & Biliary Sciences in Google Maps