A Single-center, Randomized, Controlled Clinical Study for Comparison of the Effects Between Gasless Laparoscopy-assisted and Conventional Laparoscopy-assisted Gastrectomy With D2 Lymphadenectomy for Distal Gastric Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Operative time
研究概览
简要总结
The aim of this trial is to confirm the non-inferiority of Gasless laparoscopy-assisted distal D2 radical gastrectomy to the conventional laparoscopy-assisted distal D2 radical gastrectomy for the treatment of advanced gastric cancer patients (T2-4a, N0-3, M0).
详细描述
The primary end point was operative time for Gasless laparoscopy-assisted distal D2 radical gastrectomy and conventional laparoscopy-assisted distal D2 radical gastrectomy. The secondary outcomes of interest were intraoperative vital signs; postoperative pain; and surgeon satisfaction for D2 radical 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
- Single (Participant)
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
- •Age >18 and <75 years old;
- •The gastric primary lesion is diagnosed as gastric adenocarcinoma by endoscopic biopsy histopathologic techniques (papillary adenocarcinoma [pap], tubular adenocarcinoma [tub], mucinous adenocarcinoma [muc], signet ring cell carcinoma [sig], and poorly differentiated adenocarcinoma [por]);
- •Preoperative clinical staging of T2-4a, N0-3, M0 (see preoperative assessment program; tumor staging is in accordance with AJCC-7th TNM);
- •It is expected that R0 surgical results will be obtained by distal subtotal gastrectomy and D2 lymph node dissection (also applies to multiple primary tumors)
- •Preoperative ECOG status score of 0/1;
- •Preoperative ASA (American society of anesthesiology) class of I -III;
- •Patients signed informed consent.
排除标准
- •Pregnant or lactating women;
- •Serious mental illness;
- •History of abdominal surgery (except for laparoscopic cholecystectomy);
- •History of gastric surgery (including ESD/EMR for gastric cancer);
- •Preoperative imaging examination suggests regional integration enlargement of lymph nodes (maximum diameter ≥3 cm)
- •Other malignant disease history within five (5) years;
- •Patients who received or were recommended a new adjuvant therapy;
- •History of unstable angina or myocardial infarction within six (6) months;
- •History of cerebral infarction or cerebral hemorrhage within six (6) months;
- •History of sustained systemic corticosteroid therapy within one (1) month;
- •Patients requiring simultaneous surgical treatment of other diseases;
- •Gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery;
- •Pulmonary function test with FEV1 <50% of the expected value.
结局指标
主要结局
Operative time
时间窗: During procedure.
The primary end point was operative time for Gasless Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy and conventional Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy.
次要结局
- End-tidal carbon dioxide(Through study completion, an average of 2 year.)
- Blood pressure(Through study completion, an average of 2 year.)
- Death(Through study completion, an average of 2 year.)
- Estimated blood loss(Through study completion, an average of 2 year.)
- Heart rate(Through study completion, an average of 2 year.)
- Complications(Through study completion, an average of 2 year.)
- Blood transfusion(Through study completion, an average of 2 year.)
- Tumor size(Through study completion, an average of 2 year.)
研究者
Xue Yingwei
Director, Head of Gastrointestinal surgery, Principal Investigator, Clinical Professor
The Third Affiliated Hospital of Harbin Medical University