A Prospective Multicenter, Open Study on the Safety and Efficacy of "Compont Medical Glue" in the Treatment of Esophagogastric Varices
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,200
- 试验地点
- 1
- 主要终点
- The Occurrence Rate Of Different Adverse Event
研究概览
简要总结
To observe the Safety and Efficacy of Compont Medical Glue in the Treatment of Esophagogastric Varices.
详细描述
"Compont Medical Glue" is a kind of histoacryl producted by Compont Company. It has been used to treat esophagogastric varices for several years. This study is a prospective multicenter,open study on the safety and efficacy of Compont Medical Glue in the treatment of esophagogastric varices. Weather the patient receiving injection of Compont Medical Glue is according to the degree of esophageal-gastric varices and is decided by the experienced endoscopic physicians. No additional intervention will be given to the patients, no matter whether patients are participated in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Esophagogastric varices caused by portal hypertension with or without history of bleeding and no matter whether emergency bleeding.
- •Patients may need to receive injection of histoacryl.
- •Have signed informed consent.
排除标准
- •Allergic to formaldehyde or cyanoacrylate.
- •Women who are pregnant or breast-feeding.
- •With contraindications of endoscopic exam.
- •Computed tomography(CT)/Computed tomography angiography(CTA) shows that patient with severe portosystemic shunt.
- •Large amount of blood accumulated in the stomach severely affects the endoscopic vision clarity.
- •Other reasons that researcher think the patient is unsuitable for participating in the study.
结局指标
主要结局
The Occurrence Rate Of Different Adverse Event
时间窗: Up to 2 months after the injection of histoacryl.
Chest Pain/Epigastric Pain: Appears within 24 hours after injection of Compont Medical Glue and painkillers are used. Short-term Haemorrhage: Appears within 24 hours after injection of Compont Medical Glue. Glue Injection Related Bleeding: Appears within 2 months after injection of Compont Medical Glue confirmed by endoscopy. Fever: Patient has a fever over 38.0℃ within 3 days after injection of Compont Medical Glue. Ectopic Embolization: Appears within 3 days after injection of Compont Medical Glue and was confirmed by auxiliary examinations. Local Mucosal Necrosis: Local mucosal necrosis or ulcer appears around the injection poin within 2 months after injection of Compont Medical Glue.
次要结局
- Bleeding Rate(14 days and 2 months after injection of histoacryl.)
- Rebleeding Rate(14 days and 2 months after injection of histoacryl.)
研究者
Shiyao Chen
Director of department of Gastroenterology
Shanghai Zhongshan Hospital