Efficacy and Safety of Early TIPS (Transjugular Intrahepatic Portosystemic Shunts) in the Management of Cirrhosis With Recurrent Ascites.
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Transplant free survival in both groups
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing.
排除标准
- •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)
- •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)
研究组 & 干预措施
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.
干预措施: Standard Medical Treatment (Other)
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.
干预措施: Transjugular Intrahepatic Portosystemic Shunt (Procedure)
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.
干预措施: Standard Medical Treatment (Other)
结局指标
主要结局
Transplant free survival in both groups
时间窗: 1 year
次要结局
- Incidence of Bleeding in both groups(1 year)
- Reduction in HVPG from baseline in both groups(12 month)
- Incidence of Hepatic Encephalopathy in both groups(1 year)
- Overall survival in both groups(1 year)
- Incidence of Acute Kidney Injury new complications in both groups(1 year)
- Incidence of Spontaneous bacterial Peritonitis in both groups(1 year)
- Incidence of hyponatremia in both groups(1 year)