Clinical trial · Observational
Lymph Node Staging System With a Novel Concept for Gastric Cancer: a Hybrid Type of Topographic and Numeric Ones
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrectomy for Gastric Cancer | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- TNM 7th edition
- description
- staged by the current TNM 7th edition of AJCC/UICC
- interventionNames
- Procedure: gastrectomy
- label
- new TNM stage
- description
- staged by new TNM stage with new lymph node staging concept
- interventionNames
- Procedure: gastrectomy
Primary outcomes (1)
- measure
- Prognostic performance
- timeFrame
- participants will be followed for the duration of survival, an expected average of 36 months.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDCrew 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
- BACKGROUNDBrierley 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
- BACKGROUNDKarpeh 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
- BACKGROUNDSayegh 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
- BACKGROUNDFujii 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