Clinical trial NCT06135571: Study on the No.253 Lymph Node Metastasis Patterns in Left-Sided Colon and Rectal Cancer
Official title: Real World Registry Study on the No.253 Lymph Node Metastasis Patterns in Left-Sided Colon and Rectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Lymph Node Metastasis
Keywords: Left-sided colorectal cancer
Lymph node dissection
No.253 lymph node
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Peking University Cancer Hospital & Institute
name: China-Japan Friendship Hospital
name: Chinese PLA General Hospital
First posted: 2023-11-18
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Metastatic rate of No.253 lymph node
timeFrame: About 10 days after surgery
Secondary outcomes:
measure: Number of harvested lymph nodes
timeFrame: About 10 days after surgery
measure: Incidence of postoperative complications
timeFrame: 30 days after surgery
measure: 5-year local recurrence rate
timeFrame: 5 years after surgery
measure: 5-year disease free survival rate
timeFrame: 5 years after surgery
measure: 5-year overall survival rate
timeFrame: 5 years after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijng
Study officials:
References: