Prophylactic and Endoscopic Clip Placement to Prevent Clinically Significant Post Wide Field Endoscopic Mucosal Resection Bleeding - a Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Post-Procedural Bleeding
研究概览
简要总结
Patients will be randomised to have endoscopic clips applied to the Endoscopic Mucosal Resection (EMR) site following complete removal of the lesion, or will not receive clips and proceed with standard of care.
详细描述
The outlined literature suggests that colonic post EMR bleeding may be prevented by the use of prophylactic endoscopic clips. There has thus far been no prospective study to confirm this concept. The ideal way to prove the hypothesis is to conduct a randomised controlled trial to evaluated the use of prophylactic clip placement on the EMR resection defect, for the purpose of preventing delayed bleeding in colonic wide field EMR (lesions>20mm). Given the significantly increased rate of bleeding in the proximal colon, clip placement in this location may have the greatest benefit. If it is proven that such a prophylactic technique is effective and safe, it may lead to significantly decreased patient morbidity and health care resources associated with the management delayed bleeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Can give informed consent to trial participation
- •Lesion size greater than 20 mm
- •Lesion proximal to and inclusive of mid transverse colon
- •Laterally spreading or sessile polyp morphology
排除标准
- •Previous resection or attempted resection of lesion
- •Clip deployed prior to the completion of the EMR
- •Major intraprocedural bleeding not treatable by coagulation
- •Endoscopic appearance of invasive malignancy
- •Age less than 18 years
- •Pregnancy
- •Active Inflammatory colonic conditions (e.g. inflammatory bowel disease)
- •Use of anticoagulant or antiplatelet agents other than aspirin less than 5 days prior to procedure
- •American Society of Anesthesiology (ASA) Grade IV-V
结局指标
主要结局
Post-Procedural Bleeding
时间窗: 14 days
Clinically significant post colonic wide-field EMR bleeding (CSPEB)
次要结局
- Safety success(18 months)
研究者
Professor Michael Bourke
Director of Gastrointestinal Endoscopy
Western Sydney Local Health District