NCT04164095尚未招募不适用
A Multicenter Randomized Controlled Study of the Effect of Laparoscopic Preservation of the Pylorus and Vagus Nerve on the Postoperative Quality of Life in Patients With Early Gastric Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- EORTC-QLQ-C30
研究概览
简要总结
For the patients with early gastric cancer (T1), preoperative evaluation (gastroscope, ultrasound gastroscope and abdominal enhanced CT) showed that the tumor was located in the body of the stomach, and the margin was enough to retain the pylorus and non lymph node metastasis (N0). Lappg (D1 + lymph node dissection) and traditional laparoscopic distal gastrectomy (BII type anastomosis, D1 + lymph node dissection) were included A control study was conducted to evaluate the influence of two surgical methods on the long-term quality of life of patients after operation
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
- •18 years old < age < 75 years old;
- •primary gastric lesions were diagnosed as gastric adenocarcinoma by biopsy;
- •the preoperative clinical stage was T1N0M0 according to ajcc-7thtnm;
- •it is predicted that R0 can be obtained by pylorogastric gastrectomy and D1 + lymph node dissection;
- •preoperative ECoG physical state score 0 / 1;
- •preoperative ASA score I-III;
- •informed consent of patients.
排除标准
- •pregnant or lactating women; suffering from serious mental illness;
- •the history of upper abdominal surgery (except laparoscopic cholecystectomy);
- •history of gastric surgery (including ESD / EMR for gastric cancer);
- •preoperative imaging examination showed regional enlarged lymph nodes;
- •having other malignant diseases within 5 years;
- •patients with gastric cancer who have received new adjuvant therapy or recommended new adjuvant therapy;
- •there was a history of unstable angina or myocardial infarction within 6 months;
- •have a history of cerebral infarction or cerebral hemorrhage within 6 months;
- •there was a history of continuous systemic corticosteroid therapy within 1 month;
- •simultaneous surgical treatment of other diseases is needed;
- •gastric cancer with complications (hemorrhage, perforation, obstruction) requires emergency surgery;
- •FEV1 of pulmonary function examination was less than 50% of the predicted value.
结局指标
主要结局
EORTC-QLQ-C30
时间窗: 5 years
score: 0-100. more global and functional scales is better. less symptom scales is better
次要结局
未报告次要终点
研究者
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