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

Gastrectomy for Gastric Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01961791
• Other study ID #: 4-2012-0798
• Status: Completed
• Phase: N/A
• First received: October 9, 2013
• Last updated: October 9, 2013
• Start date: January 2000
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board (Severance Hospital)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6025
• Est. completion date: September 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Gastrectomy for Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Surgery, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. — View Citation

Crew KD, Neugut AI. Epidemiology of gastric cancer. World J Gastroenterol. 2006 Jan 21;12(3):354-62. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No