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临床试验/NCT01961791
NCT01961791已完成不适用

Lymph Node Staging System With a Novel Concept for Gastric Cancer: a Hybrid Type of Topographic and Numeric Ones

Yonsei University1 个研究点 分布在 1 个国家目标入组 6,025 人开始时间: 2000年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6,025
试验地点
1
主要终点
Prognostic performance

研究概览

简要总结

For staging the status of lymph node metastasis in gastric cancer, typographic based staging system was applied until last decade, especially in Eastern countries. However the old typographic lymph node staging system in gastric cancer was too complicated and less accurate for predicting the prognosis. Now the numeric based lymph node staging system is used in both East and West, but it include problems: no information on the anatomical extent of the disease, preoperative lymph node staging is nearly impossible, failure to provide an appropriate treatment plan, cannot represent the extent of lymph node dissection. We designed simple and specifically representing the anatomic extent of the disease for staging the status of lymph node in gastric cancer. Thus we compared its prognostic performance of this new staging system with those of the current TNM 7th edition of AJCC/UICC.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients were pathologically confirmed as primary gastric cancer
  • patients underwent gastrectomy with curative intent.

排除标准

  • Patients underwent minimally invasive surgery
  • patients with any distant metastases including peritoneal seeding and para-aortic LNs metastasis)
  • when the location of lymph nodes were not divided
  • patients underwent chemotherapy preoperatively
  • patients had metastatic lymph nodes with unclear location

结局指标

主要结局

Prognostic performance

时间窗: participants will be followed for the duration of survival, an expected average of 36 months.

The overall survival (OS) was used to evaluate the prognosis after gastrectomy. The Kaplan-Meier method and log-rank test were applied to analyze the OS. In addition, the Cox proportional hazards model was used to estimate hazard ratios (HRs). To compare the discrimination of each stage, the Kaplan-Meier curves from each stage in both staging systems was used. For comparing prognostic performance of each staging system, Harrell C-index (for measuring the predictive accuracy of survival outcome) were used.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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