Evaluation of the Efficacy of Platelet-rich Plasma (PRP) on Advanced Endoscopic Resection Techniques
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Prevention of delayed bleeding: percentage of participants with delayed bleeding
研究概览
简要总结
To avoid complications secondary to advanced endoscopic resection techniques (Endoscopic Mucosal Resection -EMR- or Endoscopic Submucosal Disection -ESD-) the endoscopists have to avoid deep thermal damage and increase mucosal healing. Platelet-rich plasma (PRP) has demonstrated efficacy in preclinical endoscopic resection models.
详细描述
Background:To avoid complications secondary to advanced endoscopic resection techniques (Endoscopic Mucosal Resection -EMR- or Endoscopic Submucosal Disection -ESD-) the endoscopists have to avoid deep thermal damage and increase mucosal healing. Platelet-rich plasma (PRP) has demonstrated efficacy in preclinical endoscopic resection models.
Aim: Evaluate the efficacy of PRP on participants submitted to advanced endoscopic resection techniques: EMR or ESD.
Material and Methods
The investigators have evaluated a prospective clinical study. The investigators have included 12 participants submitted to EMR or ESD. Patients were informed and accepted to participate with a written consent. Prior to endoscopy PRP was obtained from autologous blood with a comercial kit. Submucosal injection with PRP were performed prior to resection. Resection was performed with standard technique. Participants were followed-up after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Endoscopic lesion higher than 40mm in diameter submitted to endoscopic resection (EMR or eSD)
排除标准
- •Ineligibility to endoscopic resection
研究组 & 干预措施
Submucosal injection with PRP
All participants in the study received submucosal injection of PRP prior to endoscopic resection
干预措施: Platelet-rich plasma (Drug)
结局指标
主要结局
Prevention of delayed bleeding: percentage of participants with delayed bleeding
时间窗: 28 days after resection
Delayed bleeding occurs between 13-15% of patients submitted to advanced resection techniques. The aim of this study is to evaluate the efficacy of PRP in the prevention of this complication
Prevention of coagulation syndrome (or postpolipectomy syndrome): percentage of participants with coagulation syndrome
时间窗: 5 days after resection
Coagulation syndrome occurs in around 5-7% of patients submitted to EMR or ESD. The aim is to evaluate the efficacy of PRP in the prevention of this complication
次要结局
未报告次要终点
研究者
Vicente Lorenzo-Zúñiga García
Study Principal Investigator
Germans Trias i Pujol Hospital