"To Study the Impact of Balloon-occluded Retrograde Transvenous Obliteration (BRTO)/Plug Assisted Retrograde Transvenous Obliteration (PARTO) Mediated Portal Flow Modulation in Reduction of Ammonia and Improvement in Organ Volume and Functionality in Patients of Cirrhosis With LR Shunt - A Randomized Trial.ImPARTO Trial"
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Improvement in covertHepatic Encephalopathy in both groups.
研究概览
简要总结
The informed consent will be obtained from the participants in the study. The study will be conducted on indoor patients, Department of Hepatology ILBS, New Delhi. This will be a Pilot study (sample size 25 cases in each arm) with 50% chances of each patient to randomized into each arm(1:1 randomization) .
Study Population - Patients with hepatic encephalopathy with LR shunt admitted in wards/HDU (High Dependency Unit)/LC ICU(Liver Coma ICU).
Study design-Randomized controlled Trial
Study period- 1 year.
Sample Size-Single Centre prospective RCT
- Sample size- Pilot study (sample size 25 cases in each arm)
- Follow up duration-6 months
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child A and B cirrhotic patients with Gastro/lieno-renal shunt of >8 mm.
- •Covert or Overt HE
- •Age 18 to 70 years
排除标准
- •Intractable ascites
- •PVT (with 100 % block )or PV Cavernoma and splenic vein thrombosis
- •High risk esophageal varices (till eradicated)
- •HVPG >16 mm Hg
- •Pregnancy and lactation
- •Refusal to participate in the study
结局指标
主要结局
Improvement in covertHepatic Encephalopathy in both groups.
时间窗: 1 year
Covert HE or overt HE will be analysed using clinical examination(west haven grading), specialised tests like stroop test, CFF(critical flicker frequency) or in rare cases EEG can be done.
次要结局
- Changes in portal flow in both groups.(1 year)
- Number of patients with adverse effects of PARTO/BRTO (Balloon-occluded retrograde transvenous obliteration) in both groups.(1 year)
- Number of participants with Liver transplant or death in both groups.(1 year)
- Change in MELD (Model for End Stage Liver Disease) by >5 point improvement in both groups.(6 months)
- Change in ammonia level in both groups(1 year)
- Incidence of ascites in both groups(1 year)
- Incidence of acute variceal bleed in both groups.(1 year)
- Change in CTP (Child-Pugh score) by 2 points improvement in both groups.(6 months)
- Number of patients with prevention of Gastro-Variceal bleed in both groups.(1 year)