NCT02246153Unknown3 期
Morbidity and Mortality of Laparoscopy-assisted and Open Distal Gastrectomy for Gastric Cancer in the Elderly Patients: A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Postoperative complication rate
研究概览
简要总结
- Laparoscopy-assisted distal gastrectomy for the treatment of early gastric cancer (EGC) has been supported by high-quality evidence, and the high-level evidence for advanced gastric cancer based on large prospective randomized controlled trial as CLASS-01、JCOG 0901, KLASS -02 is still awaited.Hopefully, it would have also gained the solid evidence of laparoscopy-assisted distal gastrectomy for the treatment of advanced gastric cancer (AGC).
- China has entered the aging society since 1999. Among the GC patients in China, the average age is 65 years old, which makes increasing attempts to explore laparoscopic techniques in the treatment of elderly patients.
- Nowadays, a considerable proportion of elderly patients suffer from multiple diseases, such as hypertension, diabetes, coronary heart disease. Thus the risk of intraoperative and postoperative complications can not be ignored. Unfortunately, there are rare studies specializing into the LAG for the GC patients of > 65 years old.
- Accordingly, the comparison of intraoperative and postoperative complications between laparoscopy-assisted and open distal gastrectomy for over 65 years old patients with gastric cancer based on a randomized controlled trial is warranted.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 65 years
- •Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- •cT1-4a, 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
- •Severe mental disorder
- •History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- •History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- •Exclude the early gastric cancer feasible for ESD
- •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
研究组 & 干预措施
Laparoscopic gastrectomy
Experimental
Laparoscopy-assisted distal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
干预措施: Laparoscopic gastrectomy (Procedure)
Open gastrectomy
Active Comparator
Open distal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
干预措施: Open gastrectomy (Procedure)
结局指标
主要结局
Postoperative complication rate
时间窗: 30 days
30 day morbidity and mortality
次要结局
- Postoperative recovery index(7 days)
- Postoperative pulmonary complications(30 days)
研究者
Guoxin Li
M.D.,Ph.D., F.R.C.S.
Nanfang Hospital, Southern Medical University
研究点 (1)
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