Trial of Monthly Versus Bi-weekly Endoscopic Variceal Ligation for the Prevention of Esophageal Variceal Rebleeding
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- variceal rebleeding rate
研究概览
简要总结
Many physicians suggest repeating EVL every 1-2 weeks until esophageal varices are obliterated to prevent variceal rebleeding， however, the evidences supporting the efficacy of EVL intervals of 1-2 weeks are insufficient.This randomized controlled study was conducted in order to compare the long-term results of EVL when performed at two different results from monthly and bi-weekly treatments.
详细描述
Endoscopic variceal ligation (EVL) is a safe and simple procedure now being used on a widening scale. A lot of patients who undergo endoscopic treatment for esophageal varices eventually require additional treatment for recurrent varices. Many physicians suggest repeating EVL every 1-2 weeks until esophageal varices are obliterated to prevent variceal rebleeding， however, the evidences supporting the efficacy of EVL intervals of 1-2 weeks are insufficient.This randomized controlled study was conducted in order to compare the long-term results of EVL when performed at two different results from monthly and bi-weekly treatments.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute or recent bleeding from esophageal varices;
- •portal hypertension caused by cirrhosis;
- •age between 18 and 80 yr.
排除标准
- •history of endoscopic, pharmacological, interventional or surgical treatment of esophageal varices;
- •presence of liver failure with a serum total bilirubin concentration greater than 3 mg/dL;
- •presence of hepatocellular carcinoma or other malignancy;
- •an association with a cerebral vascular accident, uremia, acute coronary syndrome, or other severe illness;
- •history of gastric variceal bleeding;
- •encephalopathy of stage II or worse;
- •failure to control initial variceal bleeding;
- •death within 48 h of admission;
- •refusal to participate in the trial.
结局指标
主要结局
variceal rebleeding rate
时间窗: 2 years
次要结局
- gastrointestinal rebleeding rate(2 years)
- number of sessions required to abstain variceal obliteration(2 years)
- variceal obliteration rate(2 years)
- adverse events(2 years)
- mortality(2 years)