Lymph Node Staging System With a Novel Concept for Gastric Cancer: a Hybrid Type of Topographic and Numeric Ones

October 9, 2013 updated by: Yonsei University
For staging the status of lymph node metastasis in gastric cancer, typographic based staging system was applied until last decade, especially in Eastern countries. However the old typographic lymph node staging system in gastric cancer was too complicated and less accurate for predicting the prognosis. Now the numeric based lymph node staging system is used in both East and West, but it include problems: no information on the anatomical extent of the disease, preoperative lymph node staging is nearly impossible, failure to provide an appropriate treatment plan, cannot represent the extent of lymph node dissection. We designed simple and specifically representing the anatomic extent of the disease for staging the status of lymph node in gastric cancer. Thus we compared its prognostic performance of this new staging system with those of the current TNM 7th edition of AJCC/UICC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6025

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Surgery, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients who underwent gastrectomy with lymph node dissection for gastric cancer in Yonsei University Hospital, Seoul

Description

Inclusion Criteria:

  • patients were pathologically confirmed as primary gastric cancer
  • patients underwent gastrectomy with curative intent.

Exclusion Criteria:

  • Patients underwent minimally invasive surgery
  • patients with any distant metastases including peritoneal seeding and para-aortic LNs metastasis)
  • when the location of lymph nodes were not divided
  • patients underwent chemotherapy preoperatively
  • patients had metastatic lymph nodes with unclear location

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TNM 7th edition
staged by the current TNM 7th edition of AJCC/UICC
Procedure: gastrectomy
gastrectomy with D1 + lymph node dissection for clinically early gastric cancer, and gastrectomy with D2 lymph node dissection for clinically advanced gastric cancer
new TNM stage
staged by new TNM stage with new lymph node staging concept
Procedure: gastrectomy
gastrectomy with D1 + lymph node dissection for clinically early gastric cancer, and gastrectomy with D2 lymph node dissection for clinically advanced gastric cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic performance
Time Frame: participants will be followed for the duration of survival, an expected average of 36 months.
The overall survival (OS) was used to evaluate the prognosis after gastrectomy. The Kaplan-Meier method and log-rank test were applied to analyze the OS. In addition, the Cox proportional hazards model was used to estimate hazard ratios (HRs). To compare the discrimination of each stage, the Kaplan-Meier curves from each stage in both staging systems was used. For comparing prognostic performance of each staging system, Harrell C-index (for measuring the predictive accuracy of survival outcome) were used.
participants will be followed for the duration of survival, an expected average of 36 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

October 9, 2013

First Submitted That Met QC Criteria

October 9, 2013

First Posted (Estimate)

October 11, 2013

Study Record Updates

Last Update Posted (Estimate)

October 11, 2013

Last Update Submitted That Met QC Criteria

October 9, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2012-0798

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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