Trial Title:
Study on the No.253 Lymph Node Metastasis Patterns in Left-Sided Colon and Rectal Cancer
NCT ID:
NCT06135571
Condition:
Colorectal Cancer
Lymph Node Metastasis
Conditions: Official terms:
Colorectal Neoplasms
Neoplasm Metastasis
Lymphatic Metastasis
Conditions: Keywords:
Left-sided colorectal cancer
Lymph node dissection
No.253 lymph node
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
Laparoscopic colorectal surgery
Description:
Patients underwent laparoscopic left colectomy, sigmoid resection or rectal surgery
according to the location of tumor.
Arm group label:
Cohort of left-sided colorectal cancer
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.
Criteria for eligibility:
Study pop:
Patients with left-sided colorectal cancer (left colon cancer, sigmoid cancer, rectal
cancer) underwent laparoscopic surgery with dissection of No.253 lymph node.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi Xiao, Dr.
Phone:
13366036387
Investigator:
Last name:
Yi Xiao, Dr.
Email:
Principal Investigator
Facility:
Name:
China-Japan Friendship Hospital
Address:
City:
Beijing
Zip:
100029
Country:
China
Status:
Recruiting
Contact:
Last name:
Lei Zhou, Dr.
Phone:
13910279583
Investigator:
Last name:
Lei Zhou, Dr.
Email:
Principal Investigator
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Aiwen Wu, Dr.
Phone:
13911577190
Investigator:
Last name:
Aiwen Wu, Dr.
Email:
Principal Investigator
Facility:
Name:
Chinese PLA General Hospital
Address:
City:
Beijing
Zip:
100141
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaohui Du, Dr.
Investigator:
Last name:
Xiaohui Du, Dr.
Email:
Principal Investigator
Start date:
September 1, 2023
Completion date:
September 1, 2026
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
China-Japan Friendship Hospital
Agency class:
Other
Collaborator:
Agency:
Chinese PLA General Hospital
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06135571
