Systematically Mediastinal Lymph Node Dissection (SLND) Versus Non-Dissection Following Endoscopic Submucosal Dissection (ESD) for T1a Stage Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 102
- 主要终点
- DFS
研究概览
简要总结
This is a study from Fujian Cancer Hospital Thoracic of Surgery Project, numbered as FJCHTOSP-1. Systematically mediastinal Lymph Node Dissection (SLD) Versus Non-Dissection Following Endoscopic Submucosal Dissection (ESD) for T1a Stage Esophageal Squamous Cell Carcinoma: a single-center, prospective clinical trial.
详细描述
Participants will be evaluated for inclusion criteria and exclusion criteria, and then sign informal consent if desired. Participants will be randomly assigned to the intervention according to a prepared random tables. Participants in the systematically mediastinal lymph node dissection (SLND) group will receive systematically mediastinal lymph node dissection, while those in the non-SLND group will not receive mediastinal lymph node dissection. The primary endpoint is 3-year disease-free survival (DFS).
The sample size are estimated with reference to investigators' previous data, in which the 3-year DFS was 62.7% for patients diagnosed with T1a Stage Esophageal Squamous Cell Carcinoma and underwent Endoscopic Submucosal Dissection without SLND. Investigators assumed that if 3-year DFS of patients in SLND group was over 80%, then investigatorswould deem the SLND group to be superior to the non-SLND group. The sample size are estimated to be 102. Therefore, the total number of patients enrolled are designed to be 102.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical stage T1aN0M
- •A lesion detected on Endoscopic Ultrasound featured as T1a stage.
- •Age 18 to
- •Patients who have signed the informed consent form.
排除标准
- •• Other than invasive adenocarcinoma by pathological analysis.
- •Not complete resected or curative intent.
- •Patients who have history of other malignant tumors.
- •Patients who have history of thoracic surgery.
- •Patients who have received radiation, chemotherapy or other treatments previously.
研究组 & 干预措施
Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection
T1a Stage Esophageal Squamous Cell Carcinoma undergo Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection
干预措施: Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection (Procedure)
Endoscopic Submucosal Dissection without Systematically mediastinal Lymph Node Dissection
T1a Stage Esophageal Squamous Cell Carcinoma just recieve Endoscopic Submucosal Dissection treatment, not undergo Systematically mediastinal Lymph Node Dissection
干预措施: Endoscopic Submucosal Dissection without SLND (Procedure)
结局指标
主要结局
DFS
时间窗: From enrollment to the end of treatment at 3 years
disease-free survival
次要结局
未报告次要终点