A Phase II Clinical Trial of Mediastinoscopic-assisted Transhiatal Laparoscopic Esophagectomy for Early-stage Thoracic Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Disease-Free Survival (DFS) and Overall Survival (OS)
研究概览
简要总结
Brief Summary The pathological type of esophageal cancer (EC) in most patients in East Asia is esophageal squamous cell carcinoma (ESCC). Surgery is the primary treatment for EC. This study compared the feasibility and safety of mediastinoscopic-assisted transhiatal laparoscopic esophagectomy (MATLE) with video-assisted thoracoscopic esophagectomy (VATE).
Thirty-five eligible patients with ESCC were assigned to the MATLE group, while seventy matched patients were assigned to the VATE group. The study compared perioperative outcomes and lymph node dissection between the two groups. Additionally, the Kaplan-Meier method was employed to estimate Disease-Free Survival (DFS) and Overall Survival (OS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •previously untreated
- •histologically confirmed
- •potentially resectable thoracic ESCC clinically staged as T1b-3N0M0 or Tis-1aN0M0 who was not suitable for endoscopic resection according to the 8th edition of the American Joint Committee on Cancer staging system and National Comprehensive Cancer Network Clinical Practice Guidelines in Esophageal and Esophagogastric Junction Cancers
- •age 18-70 years,
- •normal hematologic and organ function -Karnofsky Performance Scale (KPS) was assessed as 100 or 90
排除标准
- •a history of other malignancies
- •severe comorbidities
- •active autoimmune disease
- •prior non-infectious pneumonitis or interstitial lung disease
结局指标
主要结局
Disease-Free Survival (DFS) and Overall Survival (OS)
时间窗: DFS : From date of surgery until the date of first documented progression , assessed up to 100 months; OS :From date of surgery until the date of death, assessed up to 100 months
Disease-free Survival (DFS) was calculated from the date of the operation to the date of tumor recurrence or the last follow-up. Overall Survival (OS) was calculated from the date of the operation to the date of death or the last follow-up. Follow-up was conducted via telephone or outpatient service.
次要结局
未报告次要终点
研究者
Weijie Ye
Investigator
Sun Yat-sen University