NCT05677230已完成不适用
To Compare the Safety and Efficacy of Balloon Occluded/Plug Assisted Retrograde Transvenous Obliteration With Endoscopic Variceal Obturation for Primary Prophylaxis of Gastric Varices With Large Spontaneous Shunt: A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Proportion of patient having bleeding from GV at 12 months
研究概览
简要总结
Study population: All the consecutive patients of cirrhosis who are diagnosed to have large gastric varices without prior history of bleeding from GV, who came to OPD or endoscopy in Hepatology department of ILBS will be evaluated for inclusion.
Study design: Prospective interventional study. The study will be conducted in the Department of Hepatology ILBS.
Study period: 1.0 years
Sample size: 42
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Cirrhotic patients, with GV (GOV2 or IGV1) with eradicated or small low risk esophageal varices with gastrorenal shunt of >10 mm size amenable for BRTO/PARTO.
排除标准
- •Non-cirrhotic portal hypertension,
- •History of bleeding from GV
- •Hepatic encephalopathy grade III/IV,
- •Acute kidney injury
- •Patients on beta blocker therapy for > 6 months prior to enrollment in study
- •Hepatocellular carcinoma
- •Portal venous thrombosis
- •Presence of jaundice (bilirubin >3 mg/dl), ascites, Child C, MELD > 18
- •Advanced cardiac or pulmonary diseases
- •Patients not giving informed consent
研究组 & 干预措施
Balloon Occluded/plug assisted Retrograde Transvenous Obliteration.
Experimental
Balloon occluded/plug assisted retrograde transvenous obliteration will be done one time only.
干预措施: Balloon occluded/plug assisted retrograde transvenous obliteration. (Procedure)
Endoscopic Variceal Obturation
Active Comparator
endoscopic variceal glue therapy will be done till obturation every 3 weekly.
干预措施: Endoscopic Variceal Obturation (Procedure)
结局指标
主要结局
Proportion of patient having bleeding from GV at 12 months
时间窗: 6 months
次要结局
- Any variceal bleed(12 months)
- Change in liver (in KPa) and splenic stiffness (in KPa) after BRTO/PRTO using transient elastography(6 months)
- Change in liver (in KPa) and splenic stiffness (in KPa) after using transient elastography(6 months)
- Proportion of patients achieving complete or partial obturation of GV(6 months)
- Proportion of patients having change in grade of EV and bleeding from EV(6 months)
- Proportion of patients having appearance or worsening of PHG(6 months)
- Change in HVPG in those patients who bleed after BRTO/PRTO(6 months)
- Change in HVPG in those patients who bleed after EVO(6 months)
- Proportion of patients having new onset decompensation with ascites, jaundice or hepatic encephalopathy(6 months)
- Proportion of patient developing post procedure liver failure(6 months)
- Proportion of patient developing post acute kidney injury or sepsis(6 months)
- Duration of hospital stay poof procedure(12 months)
- Evaluation of expertise of endoscopists(12 months)
研究者
研究点 (1)
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