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.
研究组 & 干预措施
monthly EVL
Elective band ligation was applied after premedication with hyoscine-N-butylbromide (20 mg intramuscularly). A multiband ligator and video endoscopes were utilized. Ligation was initiated at or slightly below the bleeding point. During each treatment session, each varix was ligated with one or two elastic bands. Variceal obliteration success was when all varices disappeared or residual varices were too small to be ligated further. Once esophageal varices were obliterated, surveillance endoscopy was performed every 3 months for 1 year and then every 6 months to check for recurrent varices. Patients in this group will underwent endoscopic variceal ligation monthly.
干预措施: monthly Endoscopic Variceal Ligation (EVL) (Procedure)
bi-weekly EVL
Elective band ligation was applied after premedication with hyoscine-N-butylbromide (20 mg intramuscularly). A multiband ligator and video endoscopes were utilized. Ligation was initiated at or slightly below the bleeding point. During each treatment session, each varix was ligated with one or two elastic bands. Variceal obliteration success was when all varices disappeared or residual varices were too small to be ligated further. Once esophageal varices were obliterated, surveillance endoscopy was performed every 3 months for 1 year and then every 6 months to check for recurrent varices. Patients in this group will underwent endoscopic variceal ligation bi-weekly.
干预措施: bi-weekly Endoscopic Variceal Ligation (EVL) (Procedure)
结局指标
主要结局
variceal rebleeding rate
时间窗: 2 years
次要结局
- number of sessions required to abstain variceal obliteration(2 years)
- gastrointestinal rebleeding rate(2 years)
- variceal obliteration rate(2 years)
- adverse events(2 years)
- mortality(2 years)