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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

NCT ID: NCT05550701

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4575 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-05

Study Completion Date

2022-07-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Cancer Stage IV Lymph Node Yield

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

lymph node yield

Intervention Type OTHER

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.

lymph node yield

Intervention Type OTHER

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

Interventions

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lymph node yield

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

The Second Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Shuai Jiao

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Harbin, Heilongjiang, China

Site Status

Countries

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China

References

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Doll KM, Rademaker A, Sosa JA. Practical Guide to Surgical Data Sets: Surveillance, Epidemiology, and End Results (SEER) Database. JAMA Surg. 2018 Jun 1;153(6):588-589. doi: 10.1001/jamasurg.2018.0501. No abstract available.

Reference Type BACKGROUND
PMID: 29617544 (View on PubMed)

Thomas L, Li F, Pencina M. Using Propensity Score Methods to Create Target Populations in Observational Clinical Research. JAMA. 2020 Feb 4;323(5):466-467. doi: 10.1001/jama.2019.21558. No abstract available.

Reference Type BACKGROUND
PMID: 31922529 (View on PubMed)

Jiao S, Guan X, Zhang W, Wei R, Wang G, Wang X. Prognostic impact of increased lymph node yield in colorectal cancer patients with synchronous liver metastasis: a population-based retrospective study of the US database and a Chinese registry. Int J Surg. 2023 Jul 1;109(7):1932-1940. doi: 10.1097/JS9.0000000000000244.

Reference Type DERIVED
PMID: 37037584 (View on PubMed)

Other Identifiers

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SZSM201911012

Identifier Type: -

Identifier Source: org_study_id