A Prospective Clinical Study of Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Perioperative mortality
研究概览
简要总结
Objective: To evaluate the safety, feasibility and clinical efficacy of transthoracic single-hole assisted laparoscopic radical gastrectomy for Siewert Type Ⅱ adenocarcinoma of esophagogastric junction.
Methods: A prospective, single-center, one-arm study will be performed. Patients who have been diagnosed with Siewert type Ⅱ esophagogastric junction adenocarcinoma and meet the eligibility criteria will be included in the study and undergo the transthoracic single-hole assisted laparoscopic radical gastrectomy. The data of preoperative, intraoperative, postoperative and follow-up will be recorded and analyzed.
Primary study endpoints: The incidences of early postoperative complications and mortality.
The secondary study endpoints:(1) Surgery and oncology indicators ;(2) Early postoperative recovery information ;(3) 3-year disease-free survival and overall survival rate;(4) 5-year disease-free survival and overall survival.
详细描述
- Surgery and oncology indicators,such as length of operation, intraoperative blood loss, transit thoracotomy or laparotomy rate, length of proximal tumor from esophageal resection margin, number of mediastinal lymph node dissections and the positive, number of abdominal lymph node dissections and the positive, tumor type and pathological stage, etc.;
- Early postoperative recovery information ,such as time of first exhaust and defecation, time of leaving the bed, time of recovery of full and half-flow diet, time of removal of chest drainage tube, time of postoperative hospitalization, etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent of patients;
- •The tumor invaded the anatomy esophagogastric junction (EGJ), with the tumor center located at the EGJ line from 1cm above to 2cm below(SiewertⅡ).
- •The endoscopic biopsy was diagnosed with adenocarcinoma;
- •Preoperative clinical staging was cT1-4aNanyM0
- •No distant metastasis and invasion of surrounding organs were found;
- •ECOG score ranged from 0 to 1;
- •ASA score ranged from I to III.
排除标准
- •Pregnant or lactating women
- •Have a severe mental illness
- •History of esophagectomy and gastrectomy (including EMR / ESD for gastric and esophageal cancer)
- •History of other malignant tumors within 5 years
- •History of unstable angina pectoris or myocardial infarction within 6 months
- •FEV1% of pulmonary function test was less than 50% of expected value
- •History of cerebral infarction or cerebral hemorrhage within 6 months
- •Have severe liver and kidney damage
结局指标
主要结局
Perioperative mortality
时间窗: Within 30 days after surgery
The incidence of death due to the surgery
The incidences of early perioperative complications
时间窗: Within 30 days after surgery
The early perioperative complications include anastomotic fistula, anastomotic stenosis, gastrointestinal dysfunction, chest or abdominal infection, chest or abdominal hemorrhage, respiratory complications, cardiovascular and cerebrovascular accidents, embolism and so on.
次要结局
- The rate of transit thoracotomy or laparotomy(From the beginning of anesthesia to the completion of surgery)
- Intraoperative mortality(From the beginning of anesthesia to the completion of surgery)
- The tumor type(About 7 days.)
- The duration of postoperative hospitalization(Time from end of surgery to discharge,about 7 days.)
- 5-year disease-free survival rate(5 years after surgery)
- Duration of operation(From the beginning of anesthesia to the completion of surgery)
- Intraoperative blood loss(From the beginning of anesthesia to the completion of surgery)
- Proximal marginal distance(From the beginning of anesthesia to the completion of surgery)
- The number of abdominal lymph node dissections and the positive(About 7 days.)
- The pathological stage(About 7 days.)
- The duration of first exhaust(Time from end of surgery to discharge,about 7 days.)
- The duration of restoration of full flow diet(Time from end of surgery to discharge,about 7 days.)
- The duration of restoration of half-flow diet(Time from end of surgery to discharge,about 7 days.)
- The duration of first defecation(Time from end of surgery to discharge,about 7 days.)
- The number of mediastinal lymph node dissections and the positive(About 7 days.)
- The duration of first leaving the bed(Time from end of surgery to discharge,about 7 days.)
- The duration of removal of chest drainage tube(Time from end of surgery to discharge,about 7 days.)
- 3-year disease-free survival rate(3 years after surgery)
- 3-year overall survival rate(3 years after surgery)
- 5-year overall survival rate(5 years after surgery)
研究者
Wei Wang
Chief physician
Guangdong Provincial Hospital of Traditional Chinese Medicine