Colorectal CancerNCT06135571
Study on the No.253 Lymph Node Metastasis Patterns in Left-Sided Colon and Rectal Cancer
An observational study of Colorectal Cancer and Lymph Node Metastasis, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 4 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Lymph Node Metastasis
- What is being tested?
- Laparoscopic colorectal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 4 sitesChina
- Study dates
- 1 Sep 2023to 1 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100021
Yi Xiao, Dr., 13366036387
Yi Xiao, Dr.
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Lei Zhou, Dr., 13910279583
Lei Zhou, Dr.
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Aiwen Wu, Dr., 13911577190
Aiwen Wu, Dr.
- Recruiting
Chinese PLA General Hospital
Beijing, Beijng, 100141
Xiaohui Du, Dr.
Xiaohui Du, Dr.
About this study
Official title: 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
Read the 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.
- Conditions
- Colorectal Cancer, Lymph Node Metastasis
- Being tested
- Laparoscopic colorectal surgery
- Keywords
- Left-sided colorectal cancer, Lymph node dissection, No.253 lymph node
- Medical subject headings
- Colorectal Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic colorectal surgeryProcedure or surgery
Patients underwent laparoscopic left colectomy, sigmoid resection or rectal surgery according to the location of tumor.
| Study group | Role | What they receive |
|---|---|---|
| Cohort of left-sided colorectal cancer | Patients underwent curative surgery with dissection of No.253 Lymph node Receives: Procedure: Laparoscopic colorectal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metastatic rate of No.253 lymph node
Pathologically confirmed tumor cell infiltration in the No.253 lymph node
Measured: About 10 days after surgery
Secondary outcomes (5)
Number of harvested lymph nodes
Total number of lymph nodes dissected in the pathology report
Measured: About 10 days after surgery
Incidence of postoperative complications
The proportion of short-term complications occurring within 30 days post-surgery
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Sep 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Peking University Cancer Hospital & Institute, China-Japan Friendship Hospital, Chinese PLA General Hospital
- Responsible party
- Principal investigator, QIAN LIU, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135571
- Sponsor's protocol ID
- NCC4280
- Status last verified
- Nov 2023
- First submitted
- 12 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Registry Study on the No.253 Lymph Node Metastasis Patterns in Left-Sided Colon and Rectal Cancer
- ClinicalTrials.gov ID
- NCT06135571
- Acronym / sponsor ID
- NCC4280
- Conditions
- Colorectal Cancer, Lymph Node Metastasis
- Keywords
- Left-sided colorectal cancer, Lymph node dissection, No.253 lymph node
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Peking University Cancer Hospital & Institute, China-Japan Friendship Hospital, Chinese PLA General Hospital
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of left-sided colorectal cancer | – | Procedure: Laparoscopic colorectal surgeryPatients underwent curative surgery with dissection of No.253 Lymph node |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic colorectal surgeryPatients underwent laparoscopic left colectomy, sigmoid resection or rectal surgery according to the location of tumor. | Procedure or surgery | Cohort of left-sided colorectal cancer |
Primary outcome
Metastatic rate of No.253 lymph node
Time frame: About 10 days after surgery
Pathologically confirmed tumor cell infiltration in the No.253 lymph node
5 secondary outcomes
Number of harvested lymph nodes
Time frame: About 10 days after surgery
Incidence of postoperative complications
Time frame: 30 days after surgery
5-year local recurrence rate
Time frame: 5 years after surgery
5-year disease free survival rate
Time frame: 5 years after surgery
5-year overall survival rate
Time frame: 5 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Lymph Node Metastasis, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian Liu, Dr. (13601008906, fcwpumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metastatic rate of No.253 lymph node (time frame: About 10 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.