Efficacy and Safety of Endoscopic Submucosal Dissection for the Treatment of Superficial Gastric Neoplasms - An Italian Society of Digestive Endoscopy (SIED) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Recurrence rate
研究概览
简要总结
Endoscopic submucosal dissection (ESD) is the technique that has replaced surgery in the treatment of early neoplastic lesions of the stomach (LNPS). ESD of LNPS allows: a) less invasiveness compared to surgery; b) greater chances of "en bloc" resection and R0 resection compared to mucosectomy for lesions larger than 15 mm. Recent 2015 ESGE guidelines provide precise recommendations for the use of ESD in the treatment of LNPS, but Italy lacks prospective data on the efficacy and safety of ESD in a large sample of patients. A multicenter prospective observational study to create a database on the use of ESD in LNPS is essential to provide information regarding the efficacy and safety of ESD in Italy. This database would also provide information regarding the criteria applied in the use of ESD in the treatment of early gastric neoplasia
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age > 18 years old
- •Endoscopic and histologic diagnosis of gastric superficial neoplasm that can be treated by ESD according to ESGE guidelines.
- •Gastric neoplasm outside of latest ESD guidelines criteria in patients unfit for surgery
排除标准
- •Final diagnosis of non neoplastic lesion.
- •Gastric neoplasm outside of latest ESD guidelines criteria in patients fit for surgery
- •Evidence of muscolar layer invasion or limph nodes or other organs metastasis at EUS or TC when performed.
结局指标
主要结局
Recurrence rate
时间窗: 10 years
dysplastic tissue at the site of resection at follow-up endoscopy.
R0 resection rate
时间窗: 10 years
complete removal of the tumor with histologically lateral and vertical margins of the specimen free from dysplasia
Curative resection rate
时间窗: 10 years
R0 resection with combined microstaging parameters not suggestive for high metastatic potential risk.
Complication rate
时间窗: 10 years
bleeding, perforation and stenosis.
En bloc resection rate
时间窗: 10 years
removal of the lesion into a single piece.
次要结局
未报告次要终点