Scleroligation is a Safe and Effective New Technique for Eradication of Gastroesophageal Varices.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Number of sessions to complete variceal obliteration
研究概览
简要总结
Gastric varices occur in 5-33% of patients with portal hypertension. Concomitant gastro esophageal varices are the most common type. Both endoscopic sclerotherapy and band ligation are very effective in controlling acute esophageal varices bleeding and preventing rebleeding.
详细描述
Evaluation of a new scleroligation technique for management of bleeding gastro-esophageal varices regarding efficacy, complications, variceal recurrence, and survival.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cirrhotic patients presenting with an acute or recent episode of gastro-esophageal variceal bleeding.
排除标准
- •Patients were excluded if they had malignancy of any origin.
- •Any terminal illness, such as heart failure, uremia, or chronic pulmonary diseases.
- •Other potential causes of GIT bleeding.
- •Patients with previous endoscopic or surgical intervention for varices were also excluded.
研究组 & 干预措施
Sclerotherapy group
thirty patients treated by sclerotherapy for OV using ethanolamine oleate 5%.
干预措施: Sclerotherapy (Procedure)
Endoscopic band ligation group
thirty patients treated by endoscopic banding using the Euro-Ligator system.
干预措施: Band ligation (Procedure)
Sclero-ligation (SL) group
thirty patients treated by intra variceal endoscopic sclerotherapy combined with band ligation.
干预措施: Scleroligation (Procedure)
结局指标
主要结局
Number of sessions to complete variceal obliteration
时间窗: 1 year
次要结局
未报告次要终点
研究者
Sherief Abd-Elsalam
Consultant liver and GIT diseases- Tanta university hospital
Tanta University