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

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

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

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Lymph Node Metastasis
• Intervention / Treatment: Procedure: Laparoscopic colorectal surgery

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Mingguang Zhang, Dr.; Phone Number: +8613261967603; Email: zmgslimshady@163.com
• Study Contact Backup: Name: Qian Liu, Dr.; Phone Number: 13601008906; Email: fcwpumch@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Aiwen Wu, Dr.; Phone Number: 13911577190
      • Principal Investigator: Aiwen Wu, Dr.
    • Beijing, Beijing, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Lei Zhou, Dr.; Phone Number: 13910279583
      • Principal Investigator: Lei Zhou, Dr.
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Yi Xiao, Dr.; Phone Number: 13366036387
      • Principal Investigator: Yi Xiao, Dr.
  • Beijng
    • Beijing, Beijng, China, 100141
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Xiaohui Du, Dr.
      • Principal Investigator: Xiaohui Du, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with left-sided colorectal cancer (left colon cancer, sigmoid cancer, rectal cancer) underwent laparoscopic surgery with dissection of No.253 lymph node.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort of left-sided colorectal cancer; Patients underwent curative surgery with dissection of No.253 Lymph node	Procedure: Laparoscopic colorectal surgery; Patients underwent laparoscopic left colectomy, sigmoid resection or rectal surgery according to the location of tumor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metastatic rate of No.253 lymph node	Pathologically confirmed tumor cell infiltration in the No.253 lymph node	About 10 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of harvested lymph nodes	Total number of lymph nodes dissected in the pathology report	About 10 days after surgery
Incidence of postoperative complications	The proportion of short-term complications occurring within 30 days post-surgery	30 days after surgery
5-year local recurrence rate	Local recurrence refers to the return of cancer in the same area where it originally developed, typically after treatment has been completed.	5 years after surgery
5-year disease free survival rate	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.	5 years after surgery
5-year overall survival rate	Overall survival refers to the length of time from the primary treatment that patients are still alive.	5 years after surgery

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: Peking Union Medical College Hospital; Chinese PLA General Hospital; Peking University Cancer Hospital & Institute; China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: November 12, 2023
• First Submitted That Met QC Criteria: November 12, 2023
• First Posted (Estimated): November 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Lymph node dissection; Left-sided colorectal cancer; No.253 lymph node
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis; Lymphatic Metastasis
• Other Study ID Numbers: NCC4280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No