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

Recruiting

• Conditions: Colorectal Cancer; Lymph Node Metastasis
• Interventions: Procedure: Laparoscopic colorectal surgery

• Registration Number: NCT06135571
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

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.

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-12
• Study First Submitted QC: 2023-11-12
• Last Update Submitted: 2023-11-16
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort of left-sided colorectal cancer	Laparoscopic colorectal surgery	Patients underwent curative surgery with dissection of No.253 Lymph node

Primary Outcome Measures

Name	Time	Method
Metastatic rate of No.253 lymph node	About 10 days after surgery	Pathologically confirmed tumor cell infiltration in the No.253 lymph node

Secondary Outcome Measures

Name	Time	Method
5-year overall survival rate	5 years after surgery	Overall survival refers to the length of time from the primary treatment that patients are still alive.
Number of harvested lymph nodes	About 10 days after surgery	Total number of lymph nodes dissected in the pathology report
Incidence of postoperative complications	30 days after surgery	The proportion of short-term complications occurring within 30 days post-surgery
5-year local recurrence rate	5 years after surgery	Local recurrence refers to the return of cancer in the same area where it originally developed, typically after treatment has been completed.
5-year disease free survival rate	5 years after surgery	Disease free survival refers to the length of time after primary treatment during which a patient survives without any signs or symptoms of the cancer.

Trial Locations

Locations (4)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijng, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China