Comparison of 2 Days Versus 5 Days of Octreotide After Endoscopic Therapy in Preventing Early Esophageal Varices Rebleed: A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 入组人数
- 184
- 主要终点
- Esophageal varices rebleed within 5days after control of initial bleed
研究概览
简要总结
The aim of this study is to compare the efficacy of 2-days versus 5-days octreotide infusion after endoscopic therapy in preventing early esophageal varices rebleed in patients with cirrhosis.
详细描述
Variceal hemorrhage, causative of 70% of all upper gastrointestinal (GIT) bleeding events in patients with portal hypertension, remains one of the most severe and immediate life-threatening complications in patients with cirrhosis and constitutes the second most frequent decompensating event after ascites .
Gastro-esophageal varices are identified in about 30% of patients with compensated cirrhosis and 60% of patients with de-compensated cirrhosis . Esophageal variceal bleeding (EVB) occurs in 10-20% of cirrhotic patients per year and each bleeding episode can be associated with in-hospital mortality .
Mortality during the first episode is estimated to 15-20% but is higher in severe patients (Child Pugh C), at around 30%, whereas it is very low in patients with compensated cirrhosis (Child Pugh A) .The main predictors of bleeding in clinical practice are: large versus small varices, red wale marks, Child Pugh C versus Child Pugh A-B .
Treatment of variceal bleeding should be started as soon as bleeding is clinically confirmed, regardless the lack of confirmation by upper endoscopy . Initial therapy should be directed at restoring blood volume. Vasoactive drug therapy and antibiotic prophylaxis should be initiated as soon as AVB is suspected. Goals of therapy in AVB include the control of bleeding, as well as the prevention of early recurrence and the prevention of six-week mortality .
Starting vasoactive drugs before endoscopy decreases the incidence of active bleeding during endoscopy and facilitates endoscopic therapy, improving the control of bleeding, and potentially survival. Terlipressin, somatostatin or octreotide are accepted drugs with proven efficacy .
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Acute esophageal varices bleeding
- •Liver cirrhosis
排除标准
- •Initial failure to control variceal bleed on endoscopy
- •Other causes of GIT bleeding
- •Hepatocellular carcinoma
- •Portal vein thrombosis
- •Renal dialysis and hepatorenal syndrome
- •History of myocardial infarction
- •Pregnancy or lactation
- •Allergy to octreotide
研究组 & 干预措施
5 Days of octreotide infusion
干预措施: Octreotide (Drug)
2 Days of octreotide infusion
干预措施: Octreotide (Drug)
结局指标
主要结局
Esophageal varices rebleed within 5days after control of initial bleed
时间窗: with in 5 days after controlof initial bleeding
5 days Rebleeding means 1. Recurrence of hematemesis or melena after bleeding control 2. Sustained tachycardia more than 100 beat/ min and sudden drop of systolic blood pressure less than 100 3. A drop in hemoglobin by more than 20 percentage points from baseline 4. Transfusion of \>2 unites packed red blood cells after endoscopic intervention of variceal bleeding
次要结局
- Esophageal varices rebleed at 5 days and 6 weeks after control of initial bleed(5 days - 6 weeks after control of initial bleeding)
研究者
Mennat-Allah Mohammed El Sawaf
melsawaf
Tanta University
