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Recruiting NCT06135571

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

Observational Colorectal Cancer Lymph Node Metastasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laparoscopic colorectal surgery.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Lymph Node Metastasis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Detailed description

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.

Interventions

  • Procedure Laparoscopic colorectal surgery
    Patients underwent laparoscopic left colectomy, sigmoid resection or rectal surgery according to the location of tumor.

Primary outcome measures

  • Metastatic rate of No.253 lymph node [Time frame: About 10 days after surgery]
Secondary outcome measures (5)
  • Number of harvested lymph nodes [Time frame: About 10 days after surgery]
  • Incidence of postoperative complications [Time frame: 30 days after surgery]
  • 5-year local recurrence rate [Time frame: 5 years after surgery]
  • 5-year disease free survival rate [Time frame: 5 years after surgery]
  • 5-year overall survival rate [Time frame: 5 years after surgery]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 4 centers
  • Peking Union Medical College Hospital — Beijing
  • China-Japan Friendship Hospital — Beijing
  • Beijing Cancer Hospital — Beijing
  • Chinese PLA General Hospital — Beijing

Identifiers

NCT: NCT06135571 · NCC4280

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗