Prognostic Impact of Increased Lymph Node Yield in Colorectal Cancer Patients With Synchronous Distant Metastasis: a Population-based Study of the US Database and a Chinese Registry

Sponsor
The Second Affiliated Hospital of Harbin Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT05550701
Collaborator
National Natural Science Foundation of China (Other)
4,575
1
14.2
323.1

Study Details

Study Description

Brief Summary

The National Quality Forum has endorsed at least 12 lymph node yield (LNY) as a surgical quality indicator in colorectal cancer (CRC), but the prognostic value of adequate lymphadenectomy has rarely been investigated for CRC patients with distant metastatic disease.

Condition or Disease Intervention/Treatment Phase
  • Other: lymph node yield

Detailed Description

Data on CRC patients with synchronous liver metastasis (LM) were derived from the US Surveillance, Epidemiology, and End Results (SEER) and a Chinese registry (from two Chinese tertiary centers: The Second Affiliated Hospital of Harbin Medical University and National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College) between January 2010 and December 2017. Individual level data on patients with incident CRC were consecutively collected in both registries. The primary tumor site was divided into three subsites according to International Classification of Diseases for Oncology (ICD-O-3) topography codes: proximal colon (C18.0, C18.1, C18.2, C18.3 and C18.4), distal colon (C18.5, C18.6, C18.7) and rectum (C19.9 and C20.9). The synchronous LM were identified by imaging or histopathological examinations. Synchronous LM refers to liver lesions found within 6 months after the diagnosis of primary CRC. Patients were excluded if they did not undergo surgery for CRC, did not have data on number of LNs retrieved and their survival status was unknown.

Study Design

Study Type:
Observational
Actual Enrollment :
4575 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Prognostic Impact of Increased Lymph Node Yield in Colorectal Cancer Patients With Synchronous Distant Metastasis: a Population-based Study of the US Database and a Chinese Registry
Actual Study Start Date :
May 5, 2021
Actual Primary Completion Date :
May 30, 2022
Actual Study Completion Date :
Jul 10, 2022

Arms and Interventions

Arm Intervention/Treatment
SEER database

Data on CRC patients with synchronous liver metastasis (LM) were derived from the US Surveillance, Epidemiology, and End Results (SEER) between January 2010 and December 2017.

Other: lymph node yield
We recorded the number of lymph nodes dissected during surgery in patients with colorectal cancer

Chinese cohort

Data on CRC patients with synchronous liver metastasis (LM) were derived from two Chinese tertiary centers: The Second Affiliated Hospital of Harbin Medical University and National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College between January 2010 and December 2017.

Other: lymph node yield
We recorded the number of lymph nodes dissected during surgery in patients with colorectal cancer

Outcome Measures

Primary Outcome Measures

  1. cancer specific survival [2010.01-2017.12]

    The primary outcome was cancer specific survival (CSS), which was defined as the time interval from the synchronous LM diagnosis until cancer specific death or the end of follow-up in Chinese registry, and the CSS was defined using the SEER cause-of-death codes in SEER registry

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Data on CRC patients with synchronous liver metastasis (LM) undergo surgery for CRC, have data on number of LNs retrieved and their survival status was known
Exclusion Criteria:
  • Patients were excluded if they did not undergo surgery for CRC, did not have data on number of LNs retrieved and their survival status was unknown

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ethics and ethics of the Second Affiliated Hospital of Harbin Medical University Harbin Heilongjiang China 150000

Sponsors and Collaborators

  • The Second Affiliated Hospital of Harbin Medical University
  • National Natural Science Foundation of China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Shuai Jiao, doctor, The Second Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier:
NCT05550701
Other Study ID Numbers:
  • SZSM201911012
First Posted:
Sep 22, 2022
Last Update Posted:
Dec 21, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 21, 2022