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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06135571
• Other study ID #: NCC4280
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: September 1, 2026

Study information

• Verified date: November 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Qian Liu, Dr.
• Phone: 13601008906
• Email: fcwpumch[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Lymph Node Metastasis
• Lymphatic Metastasis
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijng
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	China-Japan Friendship Hospital, Chinese PLA General Hospital, Peking Union Medical College Hospital, Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metastatic rate of No.253 lymph node	Pathologically confirmed tumor cell infiltration in the No.253 lymph node	About 10 days after surgery
Secondary	Number of harvested lymph nodes	Total number of lymph nodes dissected in the pathology report	About 10 days after surgery
Secondary	Incidence of postoperative complications	The proportion of short-term complications occurring within 30 days post-surgery	30 days after surgery
Secondary	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
Secondary	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
Secondary	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