Prospective Randomized Trial of Laparoscopic Versus Open Gastrectomy for Advanced Gastric Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 328
- 试验地点
- 4
- 主要终点
- Disease free survival
研究概览
简要总结
The purpose of this study is to compare the short- and long-term results between the laparoscopy-assisted gastrectomy and the open gastrectomy.
详细描述
Background: The use of laparoscopic surgery in the management of advanced gastric cancer (AGC) has not yet met with widespread acceptance and remains limited to only a few centers.
Intervention: According to tumor pathological stage (JGCA, 2nd English ed), location of tumor, and patient clinical condition, a laparoscopy-assisted radical gastrectomy and open gastrectomy were performed. Laparoscopy-assisted radical gastrectomy consisted of the following procedures: 1) laparoscopic dissection of the lesser and greater omentum, ligation and division of the main vessels to mobilize the stomach under pneumoperitoneum, 2) laparoscopic D2 lymph node dissection, based on the Guidelines of the Japan Gastric Cancer Association and 3) resection of the distal two thirds (LADG), proximal third (LAPG), or total stomach (LATG), depending on the location of the tumor, followed by reconstruction by the Billroth I, Billroth Ⅱ, esophagogastrostomy, or Roux-en-Y method through a 3 to 5-cm-long minilaparotomy incision.
Follow-up schedule: All patients were monitored postoperatively by physical examination, and blood tests including a test for serum carcinoembryonic antigen (CEA) at least every three months for the first year, every six months for the next two years, and every year for the fourth and fifth year, and thereafter by abdominal ultrasonography, CT, chest radiography, and gastroscopy at least once each year.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven gastric adenocarcinoma
- •Age:older than 18 years old,younger than 80 years old
- •Preoperative stage(CT, GFS stage):cT2N0M0, cT2N1M0, cT2N2M0, cT3N0M0, cT3N1M0,cT3N2M0
- •ASA score:≤3
- •Patients with an invasion of the gastric serosa exceeding 10 cm2 according to ultrasound examination or examination during surgery were excluded
- •No history of other cancer
- •No history of chemotherapy or radiotherapy
- •Written informed consent
排除标准
- •Concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient
- •Patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy
- •Patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy)
- •ASA score:>3
- •Contraindication of laparoscopy: severe cardiac disease, abdominal wall hernias, diaphragmatic hernias, uncorrected coagulopathies, portal hypertension, pregnancy
- •Complicated case needed to get emergency operation
- •Any accompanying surgical condition needed to be performed in same time
结局指标
主要结局
Disease free survival
时间窗: 3 years
次要结局
- Complications, recurrence, quality of life measured by EORTC QLQ-C30 V 3.0 and EORTC QLQ-STO22(3 years)
研究者
Yan Shi
Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery
Southwest Hospital, China