NCT01609309Unknown3 期
Multicenter Study on Comparison of Long-term Outcome Between Laparoscopic and Open Distal Subtotal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 1,056
- 试验地点
- 14
- 主要终点
- 3-year disease free survival rate
研究概览
简要总结
- Laparoscopic distal subtotal gastrectomy with lymph node dissection as minimally invasive surgery has gained popularity for the treatment of early gastric cancer in East Asian countries, even though the long-term follow-up outcome based on multicenter randomized clinical trial (RCT) is still awaited.
- For the patient with locally advanced gastric cancer, several studies indicated that laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by experienced surgeons in high-volume specialized hospitals. However, the application of it is controversial mainly due to lack of solid evidence on the oncologic efficacy. Therefore, conventional open approach is still the current standard for advanced gastric cancer.
- Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to 80 per cent of all gastric cancer cases in China. Before the clinical application of laparoscopic procedure for the treatment with curative intent to advanced gastric cancer located at the middle- or lower-third of the stomach, the oncologic efficacy must be verified.
- Accordingly,the comparison of intraoperative and postoperative complications between laparoscopic and open distal subtotal gastrectomy for over 65 years old patients with gastric cancer based on a randomized controlled trial is needed.
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
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from over 18 to under 75 years
- •Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- •cT2-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
- •Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy
- •Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- •ASA (American Society of Anesthesiology) score class I, II, or III
- •Written informed consent
排除标准
- •Women during pregnancy or breast-feeding
- •Severe mental disorder
- •History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- •History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- •Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
- •History of other malignant disease within past five years
- •History of previous neoadjuvant chemotherapy or radiotherapy
- •History of unstable angina or myocardial infarction within past six months
- •History of cerebrovascular accident within past six months
- •History of continuous systematic administration of corticosteroids within one month
- •Requirement of simultaneous surgery for other disease
- •Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- •FEV1<50% of predicted values
结局指标
主要结局
3-year disease free survival rate
时间窗: 36 months
次要结局
- 3-year recurrence pattern(36 months)
- Inflammatory and immune response(7 days)
- Morbidity and mortality(30 days; 36 months)
- 3-year overall survival rate(36 months)
- Postoperative recovery course(10 days)
研究者
Guoxin Li
M.D., Ph.D.
Nanfang Hospital, Southern Medical University
研究点 (14)
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