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

NCT ID: NCT01961791

Last Updated: 2013-10-11

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

6025 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-31

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastrectomy for Gastric Cancer

Keywords

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gastric cancer, staging system, prognosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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TNM 7th edition

staged by the current TNM 7th edition of AJCC/UICC

gastrectomy

Intervention Type PROCEDURE

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

gastrectomy

Intervention Type PROCEDURE

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

Interventions

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gastrectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Surgery, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Crew KD, Neugut AI. Epidemiology of gastric cancer. World J Gastroenterol. 2006 Jan 21;12(3):354-62. doi: 10.3748/wjg.v12.i3.354.

Reference Type BACKGROUND
PMID: 16489633 (View on PubMed)

Brierley JD, Catton PA, O'Sullivan B, Dancey JE, Dowling AJ, Irish JC, McGowan TS, Sturgeon JF, Swallow CJ, Rodrigues GB, Panzarella T. Accuracy of recorded tumor, node, and metastasis stage in a comprehensive cancer center. J Clin Oncol. 2002 Jan 15;20(2):413-9. doi: 10.1200/JCO.2002.20.2.413.

Reference Type BACKGROUND
PMID: 11786568 (View on PubMed)

Karpeh MS, Leon L, Klimstra D, Brennan MF. Lymph node staging in gastric cancer: is location more important than Number? An analysis of 1,038 patients. Ann Surg. 2000 Sep;232(3):362-71. doi: 10.1097/00000658-200009000-00008.

Reference Type BACKGROUND
PMID: 10973386 (View on PubMed)

Sayegh ME, Sano T, Dexter S, Katai H, Fukagawa T, Sasako M. TNM and Japanese staging systems for gastric cancer: how do they coexist? Gastric Cancer. 2004;7(3):140-8. doi: 10.1007/s10120-004-0282-7.

Reference Type BACKGROUND
PMID: 15449201 (View on PubMed)

Fujii K, Isozaki H, Okajima K, Nomura E, Niki M, Sako S, Izumi N, Mabuchi H, Nishiguchi K, Tanigawa N. Clinical evaluation of lymph node metastasis in gastric cancer defined by the fifth edition of the TNM classification in comparison with the Japanese system. Br J Surg. 1999 May;86(5):685-9. doi: 10.1046/j.1365-2168.1999.01115.x.

Reference Type BACKGROUND
PMID: 10361195 (View on PubMed)

Other Identifiers

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4-2012-0798

Identifier Type: -

Identifier Source: org_study_id