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

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.

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Key information

Conditions

Colorectal Cancer Stage IV Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lymph Node Yield Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ethics and ethics of the Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lymph node yield

Other

We recorded the number of lymph nodes dissected during surgery in patients with colorectal cancer

Primary outcomes

cancer specific survival

Time frame: 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

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Harbin Medical University

Other

Collaborators

National Natural Science Foundation of China

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Sep 22, 2022
Registry last updated: Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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