A Randomized Controlled Trial to Assess the Role of Emergent vs Early Endoscopy in Child B and C Cirrhotic Patients With Acute Variceal Bleed (AVB)-EARLY - AVB
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Proportion of mortality within 6 weeks in Child B&C
研究概览
简要总结
Summary-Variceal bleeding - 70% of all upper gastro-intestinal bleeding episodes in patients with portal hypertension, and they result from esophageal varices (EVs), gastric varices (GVs), or ectopic varices.
Management of Acute variceal bleeding includes endoscopic variceal ligation (EVL) along with vasoactive agents. Inspite of successful hemostasis, this is associated with high variceal rebleeding (VRB) in Child B and C cirrhosis and have higher 6-week mortality rates and liver related adverse events. From time of presentation to emergent endoscopy that is 4 hours can reduce the mortality when compared early endoscopy within 4-12 hours so that mortality rate related to bleed can reduced and early hemostasis can be achieved.
Aim and Objectives -To assess the role of Emergent Endoscopy vs Early endoscopy in patients with Acute variceal bleed in CHILD B&C Cirrhosis.
Hypothesis - Early use of endoscopy along with adequate resuscitation and medical optimization in patients with Child B/C cirrhosis would lead to higher rates of endoscopic hemostasis thereby associated with better clinical outcomes, in terms of in hospital mortality rate and Liver failure related mortality in post bleed, recurrent bleeding rates.
Study population- Patient presenting with AVB as per definition in Child B &C cirrhotics.
Study design- Randomized Control Trial Non Inferior Trial. Study area- ILBS , Delhi Intervention: Patient after screening for all exclusion criteria will be randomized into either Emergent endoscopy or Early endoscopy
Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization they will undergo the Endoscopy procedure.Post procedure patient will be followed and evaluated for rebleed, mortality, liver related events if any like Hepatic encephalopathy, Ascites, Ischemic hepatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Child B and C cirrhotic patients with history of AVB.
- •Fluid responsive within 1 hour after resuscitation.
排除标准
- •EHPVO / NCPH 2.Lack of consent Pregnancy
- •Child A cirrhotics
- •Severe cardiopulmonary disease requiring optimization (Deemed contraindication for endoscopy within 12 hours).
- •Need of Dual vasopressors at presentation In Hospital patients with Bleed
- •HCC patients with AVB
- •Patients presented with AVB on going antiplatelets/anticoagulants.
结局指标
主要结局
Proportion of mortality within 6 weeks in Child B&C
时间窗: 6 weeks
次要结局
- Proportion of rebleed within 6 weeks in Chid B &C.(6 weeks)
- Proportion of patients rebleed at D5.(Day 5)
- Proportion of patients required repeated hospital admissions and number days pf hospitalisation(6 weeks)
- Proportion of LRE post bleed within 6 weeks - Ascites/ Hepatic Encephalopathy.(6 weeks)
- Proportion of patients developing Ischemic hepatitis.(6 weeks)
- Patients need of TIPS/BRTO/EUS in AVB.(6 weeks)
- Percentage of endoscopic hemostasis is achieved at 24 hours.(24 hours)
- Percentage requiring ICU saty and duration of saty post AVB(6 weeks)
研究者
Dr Sanda Kavitha
Institute of Liver and Biliary Sciences