Endoscopic Submucosal Dissection Versus Esophagectomy for Early Esophageal Carcinoma：a Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- overall survival (OS)
研究概览
简要总结
Endoscopic submucosal dissection (ESD) is a minimally invasive alternative to esophagectomy for early esophageal squamous cell carcinoma (EESCC), The data of EESCC patients who received ESD or esophagectomy were retrospectively analyzed,The aim of this study was to compare the efficacy and safety of ESD and esophagectomy in EESCC,Risk factors affecting the prognosis of patients with early esophageal squamous cell carcinoma were analyzed.
详细描述
Endoscopic submucosal dissection (ESD) is a minimally invasive alternative to esophagectomy for early esophageal squamous cell carcinoma (EESCC).The aim of this study was to compare the efficacy and safety of ESD and esophagectomy in EESCC，The data of EESCC patients who received ESD or esophagectomy were retrospectively analyzed. Overall survival (OS), disease specific survival (DSS), recurrence free survival (RFS), and procedure-related variables were compared between ESD and esophagectomy patients.Risk factors affecting the prognosis of patients with early esophageal squamous cell carcinoma were analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mucosal or submucosal squamous cell carcinoma of the esophagus
- •no lymph node involvement or distant metastasis on computed tomography (CT) or pathology;
排除标准
- •Tis premalignant lesions (high-grade intraepithelial neoplasia;HGIN)
- •patients with neoadjuvant therapy
- •patients combined with severe diseases of other organs
结局指标
主要结局
overall survival (OS)
时间窗: 10 years
OS was measured from the date of ESD or esophagectomy until death from any cause
Recurrence free survival (RFS)
时间窗: 10 years
RFS was measured from the date of ESD or esophagectomy until the first recurrence or metastasis
Disease specific survival (DSS)
时间窗: 10 years
DSS was measured from the date of ESD or esophagectomy until death resulting from ESCC
次要结局
- R0 resection(15 days)
- operation time(12 hours)
- adjuvant therapy(10 years)
- postoperative complications(30 days)
- Post-operative hospitalization days(30 days)
研究者
Zhaoshen Li
Director of Gastroenterology，Changhai Hospital；Academician of Chinese Academy of Engineering
Changhai Hospital