跳至主要内容
临床试验/NCT06135571
NCT06135571招募中不适用

Real World Registry Study on the No.253 Lymph Node Metastasis Patterns in Left-Sided Colon and Rectal Cancer

Cancer Institute and Hospital, Chinese Academy of Medical Sciences4 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,000
试验地点
4
主要终点
Metastatic rate of No.253 lymph node

研究概览

简要总结

The goal of this observational study is to learn about the the pattern of metastasis of the No.253 lymph node in colorectal cancer. The main questions it aims to answer are: 1. What are the risk factors for metastasis to the No.253 lymph node? 2.What is the prognosis for patients with metastasis to the No.253 lymph node? Patients with descending colon cancer, sigmoid colon cancer, and rectal cancer who undergo curative surgery with dissection of the No.253 lymph node are included in this study

详细描述

The No. 253 lymph node (also named as apical lymph node of inferior mesenteric artery), as the third station in the inferior mesenteric artery lymphatic system, plays a vital role in the lymphatic circulation of the descending colon, sigmoid colon, and rectum. They serve as the last barrier for tumor metastasis from regional to distant sites. The definition of the range of the No.253 lymph node primarily follows the Japanese Colorectal Cancer Treatment Guidelines: the medial boundary is the segment from the root of the inferior mesenteric artery to the origin of the left colic artery, the caudal boundary is from the origin of the left colic artery to the intersection with the inferior mesenteric vein, the lateral boundary is the outer margin of the inferior mesenteric vein, and the cranial boundary is from the horizontal section of the duodenum to the beginning of the jejunum. However, the pattern of metastasis of the No.253 lymph node in colorectal cancer remains unclear, with most studies being retrospective and showing significant differences in results. Therefore, the investigator plans to be the first internationally to carry out this retrospective, registry-based study to determine the metastasis pattern to the No. 253 lymph node in colorectal cancer. This will provide definitive clinical evidence for D3 lymph node dissection in colorectal surgery.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-75 years;
  • Underwent laparoscopic left hemicolectomy, sigmoid colectomy, or rectal cancer radical surgery.
  • Postoperative pathology confirmed as adenocarcinoma.
  • No evidence of distant metastasis.

排除标准

  • Previous history of malignant colorectal tumors.
  • Patients who have undergone multiple abdominal-pelvic surgeries.
  • Patients undergoing emergency surgery due to complications such as intestinal obstruction, intestinal perforation, or intestinal bleeding.
  • Surgery did not achieve R0 resection.
  • Patients with concurrent other malignant tumors or multiple primary colorectal cancers.
  • Patients unwilling to sign an informed consent or follow the study protocol for follow-up.

结局指标

主要结局

Metastatic rate of No.253 lymph node

时间窗: About 10 days after surgery

Pathologically confirmed tumor cell infiltration in the No.253 lymph node

次要结局

  • 5-year overall survival rate(5 years after surgery)
  • Number of harvested lymph nodes(About 10 days after surgery)
  • Incidence of postoperative complications(30 days after surgery)
  • 5-year local recurrence rate(5 years after surgery)
  • 5-year disease free survival rate(5 years after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

QIAN LIU

Professor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

研究点 (4)

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