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

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT06135571

Collaborator

Peking Union Medical College Hospital (Other), Peking University Cancer Hospital & Institute (Other), China-Japan Friendship Hospital (Other), Chinese PLA General Hospital (Other)

3,000

Enrollment

Locations

Anticipated Duration (Months)

750

Patients Per Site

20.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Lymph Node Metastasis	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 Design

Study Type:

Observational

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China	100021
2	China-Japan Friendship Hospital	Beijing	Beijing	China	100029
3	Beijing Cancer Hospital	Beijing	Beijing	China	100142
4	Chinese PLA General Hospital	Beijing	Beijng	China	100141