EndoClotTM Absorbable Polysaccharide Hemostat for Preventing Rbleeding After Endoscopic Mucosal Resection (EMR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Rebleeding rate after EMR procedure
研究概览
简要总结
Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment techniques of gastrointestinal small lesions. Postoperative rebleeding is one of the common complication following EMR. Several endoscopic hemostasis methods are currently in use. EndoClot® absorbable polysaccharide hemostat (PAPH) as a new hemostasis material was previously used for surgical hemostasis, but the therapeutic effect and safety in endoscopic application remains unknown. This study has been designed to observe the effect of rebleeding prevention after EMR.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •consecutive cases of colorectal polyps and submucosal lesions with anticipated complete removal endoscopically by EMR.
排除标准
- •severe cardiovascular diseases, liver and kidney dysfunction;
- •platelet and coagulation dysfunction (PLT < 50*109/L, INR > 2);
- •cases that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 1 month before the procedure;
- •cases unavailable for follow-up.
结局指标
主要结局
Rebleeding rate after EMR procedure
时间窗: up to 1 week
Rebleeding rate up to 1 week was obtained by clinical manifestations such as melana; decreased hemoglobin \> 20g/L; hemodynamic instability or active bleeding from mucosal defect under endoscope.
次要结局
- Mucosal healing after EMR(up to 1 month)
- gastrointestinal tract obstruction(up to 1 month)
研究者
Zhiguo Liu
Associated Professor
Xijing Hospital of Digestive Diseases