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

NCT05550701 | Completed

• 1 other identifier: SZSM201911012
• Study Type: observational
• Target: 4,575
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer Stage IV; Lymph Node Yield

Outcome Measures

Primary Outcomes (1)

• cancer specific survival

  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

  2010.01-2017.12

Study Arms (2)

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

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

Interventions

lymph node yield OTHER

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

Chinese cohort; SEER database

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Harbin, Heilongjiang, 150000, China

Location

Related Publications (3)

• 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.

  PMID: 29617544 BACKGROUND

• 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.

  PMID: 31922529 BACKGROUND

• 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.

  PMID: 37037584 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 22, 2022
• Study Start: May 5, 2021
• Primary Completion: May 30, 2022
• Study Completion: July 10, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)