Endoscopic Treatment for Local Residual Neoplasia After Endoscopic Mucosal Resection of the Colorectal Lateral Spreading Tumors (LST)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Efficacy of endoscopic treatment od local residual neoplasia (absence of neoplastic tissue in post-EMR scar proven by endoscopic and histologic examination)
研究概览
简要总结
Endoscopic mucosal resection (EMR) is considered to be a gold standard of therapy of colorectal lateral spreading tumors (LST) without significant risk for lymphatic spread. According to the investigators previous study, local residual neoplasia (LRN) after conventional endoscopic mucosal resection (EMR)occurs in up to 21% of cases. Endoscopic therapy of LRN was not sufficient in 53 % and has not been standardized yet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •patients older than 18 years
- •patients with local residual neoplasia in scar in three months after endoscopic mucosal resection for laterally spreading tumor (0-IIa > 10 mm)
- •signed informed consent
排除标准
- •incomplete endoscopic mucosal resection
- •previous therapy for local residual neoplasia
- •difficult or impossible localization of post-EMR scar
结局指标
主要结局
Efficacy of endoscopic treatment od local residual neoplasia (absence of neoplastic tissue in post-EMR scar proven by endoscopic and histologic examination)
时间窗: 6 months
Efficacious endoscopic treatment is defined as absence of neoplastic tissue in post-EMR scar proven by endoscopic and histologic examination in 6 months after endoscopic treatment od local residual neoplasia.
次要结局
未报告次要终点
研究者
Premysl Falt, M.D., Ph.D.
MUDr. Premysl Falt
Vitkovice Hospital