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

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.

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Key information

Conditions

Gastrectomy for Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Surgery, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

gastrectomy

Procedure

gastrectomy with D1 + lymph node dissection for clinically early gastric cancer, and gastrectomy with D2 lymph node dissection for clinically advanced gastric cancer

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2000
Primary completion: 2011
Study completion: 2013
First posted: Oct 11, 2013
Registry last updated: Oct 11, 2013

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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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