EndoClotTM Absorbable Polysaccharide Hemostat in Comparison With Metallic Hemoclip for Hemostasis and Preventing Post-procedure Bleeding After Endoscopic Mucosal Resection: a Prospective, Randomized Trial
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
- Hemostasis rate after EMR
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. Para-procedure bleeding is one of the common complication following EMR. Several endoscopic hemostasis methods are currently in use including metallic hemoclip. 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 randomized controlled study has been designed to compare PAPH with metallic hemoclip in their hemostatic effect of intra-procedure bleeding control and rebleeding prevention during and after EMR.
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
- •consecutive cases of colorectal polyps and submucosal tumors 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
Hemostasis rate after EMR
时间窗: Up to half an hour immediately after EMR procedure to ensure successful management is achieved.
Initial hemostatsis was observed endoscopically immediately after application of hemoclip or Endoclot. Complete hemostatsis is ensured. Endoscopic combined hemostasis or emergency surgery would be applied if severe bleeding occurred and endoscopic management fails
次要结局
- Mucosal healing after EMR(up to 1 month)
- Time taken to achieve hemostasis(Up to half an hour immediately after EMR procedure to ensure successful management is achieved.)
- Rebleeding rate after EMR procedure(up to 1 week)
- gastrointestinal tract obstruction(up to 1 month)
研究者
Zhiguo Liu
Associated Professor
Xijing Hospital of Digestive Diseases