Healing Effects of Autologous Platelet Rich Plasma on Gastric Ulcer Caused by Endoscopic Submucosal Dissection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Recovery of artificial gastric ulcer
研究概览
简要总结
In Korea, where the prevalence of gastric tumors is high, the use of ESD as a treatment for gastric cancer will continue to increase. Considering that there are no special measures to prevent side effects (bleeding, perforation, etc.) of this procedure, it is possible to reduce the large medical costs through the discovery of substances that can promote gastric mucosal healing. Mechanism of PRP-based materials in the regeneration of gastric mucosal damage can be used to understand the pathophysiology of ulcers. In the future, it can be suggested as a new treatment for gastrointestinal tract damage such as intractable ulcer, perforation, mucosal fistula, gastrointestinal bleeding caused by esophagus, small intestine and large intestine as well as ulcer treatment by endoscopic procedure.
详细描述
Background:In Korea, where the prevalence of gastric tumors is high, the use of ESD as a treatment for gastric cancer will continue to increase. Considering that there are no special measures to prevent side effects (bleeding, perforation, etc.) of this procedure, it is possible to reduce the large medical costs through the discovery of substances that can promote gastric mucosal healing. Platelet-rich plasma (PRP) has demonstrated efficacy in preclinical endoscopic resection models.
Aim: Evaluate the efficacy of PRP on participants submitted to ESD.
Material and Methods
The investigators have evaluated a prospective clinical study. The investigators have included 10 participants submitted to ESD. Patients were informed and accepted to participate with a written consent. Prior to endoscopy PRP was obtained from autologous blood with a commercial kit. Resection was performed with standard technique. Immediately after the procedure, autologous PRP is applied to the artificial gastric ulcer using endoscopic spray. Participants were followed-up after the procedure.
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
- Single (Participant)
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 submitted to endoscopic resection (ESD)
排除标准
- •Ineligibility to endoscopic resection
- •Patients who declined to participate in this study
- •Patients who had hematologic diseases
研究组 & 干预措施
Apply platelet rich plasma to the artificial gastric ulcer
干预措施: Platelet rich plasma (Drug)
Apply normal saline to the artificial gastric ulcer
干预措施: Normal saline (Drug)
结局指标
主要结局
Recovery of artificial gastric ulcer
时间窗: 2 weeks
Measure the ulcer size with an endoscopy.
次要结局
- Recovery of artificial gastric ulcer(4 weeks)
- Occurrence of postprocedure complication(4 weeks)
研究者
YooJin Lee
Assistant professor
Keimyung University Dongsan Medical Center