NCT04351321Unknown不适用
A Multicenter, Randomized, Controlled Clinical Trial of the Safety of Totally Laparoscopic Versus Laparoscopy-Assisted Total Gastrectomy for Gastric Cancer.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 560
- 主要终点
- The incidence of postoperative morbidity
研究概览
简要总结
To compare the short-term surgical safety and postoperative quality of life of totally laparoscopic versus laparoscopy-assisted total gastrectomy and to evaluate the superiority of totally laparoscopic total gastrectomy.
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
- Double (Participant, Outcomes Assessor)
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
- •Aged 18-75 years；
- •Primary lesion is diagnosed with endometrial biopsy as adenocarcinoma of the stomach or esophagogastric junction, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), mixed adenocarcinoma, etc.；
- •Clinical stage cT1N0M0, cT1N1M0, cT2N0M0；
- •The gastric primary lesion is located in the body or fundus of stomach or the esophagogastric junction. It is expected that total gastrectomy with D1+/D2 lymph node dissection achieves R0 resection (multiple primary cancers are also applicable)；
- •BMI(Body Mass Index)<30 kg/m2；
- •No history of upper abdominal surgery (except for laparoscopic cholecystectomy)；
- •No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.；
- •Preoperative ECOG (Eastern Cooperative Oncology Group) performance status score 0 or 1；
- •Preoperative ASA (American Society of Anesthesiologists) scoring I-III；
- •Sufficient vital organ functions；
- •Signed informed consent.
排除标准
- •Preoperative examination indicates disease stage cStage II or above；
- •Women during pregnancy or lactation；
- •Suffer from other malignant tumors within 5 years；
- •Preoperative body temperature ≥ 38°C or complicated with infectious diseases requiring systemic treatment；
- •Severe mental illness；
- •Severe respiratory disease；
- •Severe liver and kidney dysfunction；
- •History of unstable angina or myocardial infarction within 6 months；
- •History of cerebral infarction or cerebral hemorrhage within 6 months；
- •Continuous application of glucocorticoid within 1 month (except for topical application)；
- •Accompanied by gastric cancer complications (bleeding, perforation, obstruction, etc.) ；
- •The patient has participated in or is participating in other clinical studies (within 6 months).
结局指标
主要结局
The incidence of postoperative morbidity
时间窗: 30 days
Refers to the incidence of early postoperative complications. The early postoperative complications are defined as the events observed within postoperative 30 days.
次要结局
- Overall incidence of postoperative morbidity(12 months)
- Quality of life score(3, 6 and 12 months)
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