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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIPS+Standard Medical Treatment | Experimental | 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 Treatment | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transjugular Intrahepatic Portosystemic Shunt | Procedure | Transjugular Intrahepatic Portosystemic Shunt |
|
| Measure | Description | Time Frame |
|---|---|---|
| Transplant free survival in both groups | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival in both groups | 1 year | |
| Reduction in HVPG from baseline in both groups | 6 month | |
| Reduction in HVPG from baseline in both groups |
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Inclusion Criteria:
Exclusion Criteria:
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)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Vinay Kumar, MD | Contact | 01146300000 | drvinaybr@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences | Recruiting | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| Standard Medical Treatment | Other | 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. |
|
| 12 month |
| Incidence of Acute Kidney Injury new complications in both groups | 1 year |
| Incidence of Spontaneous bacterial Peritonitis in both groups | 1 year |
| Incidence of Hepatic Encephalopathy in both groups | 1 year |
| Incidence of Bleeding in both groups | 1 year |
| Incidence of hyponatremia in both groups | 1 year |
| ID | Term |
|---|---|
| D019168 | Portasystemic Shunt, Transjugular Intrahepatic |
| ID | Term |
|---|---|
| D011170 | Portasystemic Shunt, Surgical |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
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