A Prospective, Multicenter, Randomized, Controlled Study Comparing Surgical Efficacy Between Transhiatal/Transabdominal and Thoracoabdominal Approach for Patients With Siewert II Adenocarcinoma of Esophagogastric Junction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- 3-year disease-free survival
研究概览
简要总结
To compare transhiatal / transabdominal approach with thoracoabdominal approach for Siewert II adenocarcinoma of esophagogastric junction
详细描述
Objective
To compare the safety and clinical efficacy between transhiatal/transabdominal and thoracoabdominal approach for Siewert Ⅱ adenocarcinoma of esophagogastric junction.
Methods: A prospective, multi-center, randomized, controlled study will be performed. Patients who meet the eligibility criteria will be registered in the study and undergo radical surgery via transhiatal/transabdominal or thoracoabdominal approach. The data of preoperative, intraoperative, postoperative and follow-up will be recorded and analyzed.
The primary endpoints :3-year disease-free survival. The secondary endpoints:(1) Surgery and oncology indicators ;(2) The incidences of postoperative complications and mortality.
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
- •1.18~75 years old
- •2.The tumor center located at the esophagogastric junction(EGJ) line from 1cm above to 2cm below(SiewertⅡ) .
- •3.Histological diagnosis of adenocarcinoma
- •American Society of Anesthesiologists(ASA) physical status class is less than or equal to 3
- •5.Informed consent of patients
排除标准
- •1.Patients with distant metastasis (M1) or invasion of surrounding organs
- •2.History of esophagectomy and gastrectomy (including endoscopic mucosal resection/endoscopic submucosal dissection for gastric cancer and esophageal cancer)
- •3.History of other malignant tumors within 5 years
- •4.The researcher believes that the patient is not suitable to participate in the clinical trial
- •5.Patients who persist in withdrawing from clinical trials
研究组 & 干预措施
Thoracoabdominal approach
Radical surgery should be finished via Thoracoabdominal approach.
干预措施: thoracoabdominal approach (Procedure)
Transhiatal/transabdominal approach
Radical surgery should be finished via transhiatal/transabdominal approach.
干预措施: transhiatal/transabdominal approach (Procedure)
结局指标
主要结局
3-year disease-free survival
时间窗: 3 years after surgery
Proportion of patients without tumor recurrence from surgery to the end of the 3-year follow-up
次要结局
- The incidence of perioperative mortality(Within 30 days after surgery)
- The rate of R0-resection(About 10 days after surgery)
- The number of lymph node dissections and the positive(About 10 days after surgery)
- The duration of postoperative hospitalization(Within 6 months after surgery)
- The incidences of early postoperative complications(Within 30 days after surgery)
研究者
Lin Chen
Prof.
Chinese PLA General Hospital