Clinical trial NCT01961791: Lymph Node Staging System With a Novel Concept for Gastric Cancer: a Hybrid Type of Topographic and Numeric Ones
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrectomy for Gastric Cancer
Keywords: gastric cancer, staging system, prognosis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-10-11
Enrollment: 6025
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent gastrectomy with lymph node dissection for gastric cancer in Yonsei University Hospital, Seoul

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prognostic performance
timeFrame: participants will be followed for the duration of survival, an expected average of 36 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Yonsei University College of Medicine
Study officials:
References:
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citation: 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.
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. doi: 10.1097/00000658-200009000-00008.
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. doi: 10.1007/s10120-004-0282-7.
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