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临床试验/NCT02938481
NCT02938481已完成不适用

International Prospective Observational Cohort Study for Optimal Bowel Resection Extent and Central Radicality for Colon Cancer

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan36 个研究点 分布在 7 个国家目标入组 3,647 人开始时间: 2013年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,647
试验地点
36
主要终点
Distribution of metastatic LNs

研究概览

简要总结

The T-REX study aims to clarify the actual status of metastatic lymph node (LN) distribution in colon cancer and provide reliable evidence regarding the optimal length of bowel resection and the extent of central lymph node dissection in colon cancer surgery.

详细描述

In colon canser, the incidence of metastasis in the pericolic lymph nodes (LNs) located along the bowel and marginal artery is high. The optimal extent of bowel resection is closely associated with how we define 'regional' pericolic LNs, which should be resected because of the risk of metastasis. However, there are no standardised criteria for 'regional' LNs in the pericolic area.

To establish a consensus for the extent of bowel resection and appropriate central LN dissection, international prospective stdies focusing on the distribution of metastatic LNs along the bowel and the primary feeding artery are conducted.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Histologically proven colon adenocarcinoma
  • Pathological stage Ⅰ, Ⅱ or Ⅲ
  • Potentially curative surgery
  • Informed consent for observational data collection

排除标准

  • Tis (mucosal cancer)
  • Multiple colon cancers
  • All patients with preoperative adjuvant therapy

结局指标

主要结局

Distribution of metastatic LNs

时间窗: At the time of 4 years after surgery

Distribution of metastatic LNs

时间窗: At the time of patient registry in

次要结局

  • Prognostic outcomes according to the length of bowel resection(4 years)
  • Prognostic outcomes according to the central radicality(4 years)

研究者

发起方
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
申办方类型
Other
责任方
Sponsor

研究点 (36)

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