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

NCT01961791 | Completed

• 1 other identifier: 4-2012-0798
• Study Type: observational
• Target: 6,025
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrectomy for Gastric Cancer

Keywords

gastric cancer, staging system, prognosis

Outcome Measures

Primary Outcomes (1)

• Prognostic performance

  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.

Study Arms (2)

TNM 7th edition

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

Procedure: gastrectomy

new TNM stage

staged by new TNM stage with new lymph node staging concept

Procedure: gastrectomy

Interventions

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

TNM 7th edition; new TNM stage

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Surgery, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Related Publications (5)

• 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.

  PMID: 16489633 BACKGROUND

• 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.

  PMID: 11786568 BACKGROUND

• 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.

  PMID: 10973386 BACKGROUND

• 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.

  PMID: 15449201 BACKGROUND

• 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.

  PMID: 10361195 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Gastrectomy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 11, 2013
• Study Start: January 1, 2000
• Primary Completion: December 1, 2011
• Study Completion: September 1, 2013
• Last Updated: October 11, 2013

Record last verified: 2013-10

Locations

KR (1)