Clinical trial NCT04013074: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhoses
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Transplant free survival in both groups
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival in both groups
timeFrame: 1 year
measure: Reduction in HVPG from baseline in both groups
timeFrame: 6 month
measure: Reduction in HVPG from baseline in both groups
timeFrame: 12 month
measure: Incidence of Acute Kidney Injury new complications in both groups
timeFrame: 1 year
measure: Incidence of Spontaneous bacterial Peritonitis in both groups
timeFrame: 1 year
measure: Incidence of Hepatic Encephalopathy in both groups
timeFrame: 1 year
measure: Incidence of Bleeding in both groups
timeFrame: 1 year
measure: Incidence of hyponatremia in both groups
timeFrame: 1 year
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References: