NCT02333721Unknown不适用
Study on Long-term Outcome of Laparoscopic Spleen-Preserving D2 Lymphadenectomy With and Without No. 10 Lymph Node Dissection for Advanced Gastric Cancer
Fujian Medical University1 个研究点 分布在 1 个国家目标入组 536 人开始时间: 2015年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 536
- 试验地点
- 1
- 主要终点
- 3-year disease free survival rate
研究概览
简要总结
The purpose of this study is to explore the short-term, long-term and oncological outcomes of laparoscopic spleen-preserving No. 10 lymph node dissection in a left-sided approach for advanced middle or upper third gastric cancer not invading greater curvature.
详细描述
A prospective randomized comparison of laparoscopic spleen-preserving No. 10 lymph node dissection for gastric cancer will be performed, to evaluate the short-term, long-term and oncological outcomes. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.
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
- 10 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 75 years
- •Primary proximal gastric adenocarcinoma not invading greater curvature (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 American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- •No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
- •Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
- •American Society of Anesthesiology score (ASA) 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
- Blood transfusion(10 days)
- Morbidity and mortality(30 days; 36 months)
- 3-year overall survival rate(36 months)
- 3-year recurrence pattern(36 months)
- Time to first ambulation(10 days)
- Rates of splenectomy(1 day)
- Rates of injury to splenic vessels(1 day)
- The number of lymph node dissection(1 day)
- The variation of weight(12 months)
- The amount of abdominal drainage(10 days)
- The daily highest body temperature(7 days)
- Time to first flatus(10 days)
- Time to first liquid diet(10 days)
- Time to soft diet(10 days)
- Duration of hospital stay(10 days)
- The number of positive lymph nodes(1 day)
- Intraoperative lymph node dissection time(1 day)
- Intraoperative blood loss(1 day)
- Intraoperative injury(1 day)
- The amount of use of titanium clip(1 day)
- The rate of conversion to laparotomy(1 day)
- The variation of cholesterol(12 months)
- The variation of albumin(12 months)
- The results of endoscopy(12 months)
- The values of white blood cell count(7 days)
- The values of hemoglobin(7 days)
- The values of C-reactive protein(7 days)
- The values of prealbumin(7 days)
- The values of relevant immune cytokines(7 days)
- The Surgery Task Load Index (SURG-TLX)(1 days)
- Lymph node noncompliance rate(1 days)
- Technical performance(1 days)
研究者
Chang-Ming Huang, Prof.
Director, Principal Investigator, Clinical Professor
Fujian Medical University Union Hospital
研究点 (1)
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