NCT03478449Unknown不适用
A Single Center Randomized Prospective Study on the Criteria for Lymph Node Sorting for Pathological Examination After Curative Surgery for Gastric Cancer
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 276 人开始时间: 2018年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Migration of pN stage in gastric cancer patients
研究概览
简要总结
The aim of this study is intending to provide the optimal procedures of lymph node sorting for pathological examination after curative surgery for gastric cancer, which can discriminate the differences of the status of lymph node metastasis, pTNM classification and prognostic outcome of gastric cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) Physical conditions compliance with the requirements for curative gastrectomy
- •2) Consent to undergo the D2 lymphadenectomy
- •3) Comply with the protocol during the whole study period
- •4) No neoadjuvant therapy administration
- •5) Sign informed consent and permission of withdraw in the whole study period
- •6) Consent to provide the tissue specimens after surgery for this study
- •7) Pathological examination confirmation the adenocarcinoma of stomach before surgery
- •8) Estimation the overall survival after surgery no less than 6 months
- •9) No anesthesia or operation contraindication disease
- •10) cTanyNanyM0 stage demonstration by CT and endoscopic ultrasonography examinations
- •11) Negative cytological detection in operation
- •12) No seriously concomitance's diseases
- •13) Karnofsky Performance Scores (KPS) more than 60
排除标准
- •1) Women during pregnant stage and breast-feed stage
- •2) Women of childbearing age without any contraceptive measures
- •3) Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months
- •4) Immunosuppressive therapists for organ transplantation
- •5) Seriously uncontrolled recurrent infection
- •6) other malignant tumors
- •7) No abilities of self-knowledge or mental disorders
- •8) Participating in other clinical trials
- •9) Siewert I and II esophagogastric junction tumors
- •10) Serious internal diseases obstruction surgery
研究组 & 干预措施
Fine sorting lymph node group
Experimental
干预措施: lymph node sorting for pathological examination (Procedure)
Regional sorting lymph node group
No Intervention
结局指标
主要结局
Migration of pN stage in gastric cancer patients
时间窗: 60 months
According to the overall survival of all included patients, we will evaluate the optimal lymph node sorting method to obtain the accurately pathological stage of lymph node metastatic counts (pN stage) for prediction the prognosis of patients after curative surgery for gastric cancer.
次要结局
未报告次要终点
研究者
研究点 (1)
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