A Randomized Controlled Trial of Ligation Versus Ligation Plus Sclerotherapy in Addition to Cyanoacrylate in Patients With Gastroesophageal Varices
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- recurrence rate of variceal hemorrhage
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of two different endoscopic treatment in gastroesophageal varices in patients with liver cirrhosis: ligation versus ligation plus sclerotherapy in addition to cyanoacrylates
详细描述
Gastroesophageal variceal bleeding, which often results from portal hypertention, is known as one of the most frequent death causes of patients with liver cirrhosis. When a patient has bleeding episode, it's very likely that he/she will develop another one in the future. Endoscopic treatments such as ligation, sclerotherapy or cyanocrylates are proved to decrease the risk of re-bleeding. The purpose of this study is to evaluate the efficacy of two different endoscopic treatments in patients who have both gastric and esophageal varices with liver cirrhosis: In addition to cyanoacrylates, ligation versus ligation plus sclerotherapy.
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 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with portal hypertension caused by liver cirrhosis who presented with an acute or recent episode of gastroesophageal variceal bleeding and have previously received endoscopic treatments of ligation and cyanoacrylate. Diagnosis of liver cirrhosis or mixed cirrhosis was based on results of liver biopsy or biochemical tests and liver imaging by ultrasonography.
- •The extent of the varices range from Moderate to Severe.
- •The age of the patients range from 18 to 72 years old.
排除标准
- •Patients who had other causes for portal hypertention(CTPV,Budd-Chiari syndrome,etc.)
- •Patients with severe systemic disease (renal failure, heart failure,carcinoma other than liver cancer,etc.)
- •Patients who had contraindications for ligation,sclerotherapy or cyanoacrylate.
- •Patients who have previously received shunt or devascularization operation,TIPS.
- •Patients who had portosystemic shunt according to the results of CT scan.
结局指标
主要结局
recurrence rate of variceal hemorrhage
时间窗: Participants will be followed for up to 6 months starting from the date of randomization.
recurrence rate of variceal hemorrhage
次要结局
- eradication rate of the gastroesophageal varices(Participants will be followed for up to 6 months starting from the date of randomization.Eradication of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months.)
- recurrence rate of the gastroesophageal varices(Participants will be followed for up to 6 months starting from the date of randomization.Recurrence rate of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months.)
- mortality rate during the follow-up period(Participants will be followed for up to 6 months starting from the date of randomization.)
- incidence rate of complications associated with endoscopic treatments(Participants will be followed for up to 6 months starting from the date of randomization.)
研究者
Shiyao Chen
department of Gastroenterology
Shanghai Zhongshan Hospital