NCT Number: NCT07781319
Early gastric cancer (EGC) is increasingly diagnosed in Western countries; however, important differences remain with Eastern populations regarding staging accuracy, treatment strategies, and the risk of lymph node metastasis. While endoscopic resection is the standard treatment for selected EGC in Asia based on well-established criteria, the applicability of these criteria to Western populations remains uncertain because of differences in epidemiology, clinical practice, and pathological characteristics.
This multicenter retrospective cohort study, based on the Spanish EURECCA Registry, aims to evaluate the concordance between clinical and pathological staging, determine the real incidence and predictors of lymph node metastasis in patients with pathological T1 gastric cancer, assess the applicability of standard and expanded Asian endoscopic resection criteria in a Western cohort, and analyze long-term oncological outcomes, including recurrence and overall survival.
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All sexes
Observational
Early gastric cancer (EGC) is defined as gastric adenocarcinoma confined to the mucosa or submucosa regardless of lymph node status. Although endoscopic resection has become the standard treatment for selected patients in Eastern countries, its use in Western populations remains controversial because most recommendations are based on Asian cohorts with different epidemiological characteristics, screening strategies, and clinical practice.
Accurate preoperative staging is essential for selecting the optimal therapeutic approach. However, the concordance between clinical staging and final pathological findings remains suboptimal, particularly regarding depth of invasion and lymph node involvement. These limitations may result in both overtreatment and undertreatment of patients with EGC.
The Spanish EURECCA Registry provides a large multicenter cohort of surgically treated patients with standardized clinicopathological data collected from routine clinical practice. This study will evaluate the agreement between clinical and pathological staging, characterize the risk factors associated with lymph node metastasis, retrospectively assess the applicability of standard and expanded Asian endoscopic resection criteria in a Western population, and investigate long-term oncological outcomes. The results are expected to provide evidence supporting treatment decision-making and the potential implementation of less invasive therapeutic strategies in appropriately selected Western patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Percentage of participants in whom preoperative clinical staging (cT and cN) was concordant with final pathological staging (pT and pN). Concordance will be assessed by comparing clinical and pathological tumor depth and lymph node status.
Time frame: Baseline
Percentage of participants with pathological lymph node metastasis (pN+) among patients with pathological T1 gastric adenocarcinoma. Lymph node status will be determined from the definitive pathological examination of the surgical specimen.
Time frame: Baseline
Assessment of the proportion of patients fulfilling the standard Asian endoscopic resection criteria and evaluation of the associated risk of lymph node metastasis.
Time frame: Baseline
Assessment of the proportion of patients fulfilling the expanded Asian endoscopic resection criteria and evaluation of the associated risk of lymph node metastasis.
Time frame: Up to 5 years after surgery
Overall survival measured from the date of surgery to death from any cause or last follow-up.
Time frame: Up to 5 years after surgery
Disease-free survival measured from the date of surgery to disease recurrence, death, or last follow-up.
Time frame: Up to 5 years after surgery
Percentage of participants who develop local, regional, or distant tumor recurrence after curative-intent surgery.
Time frame: Baseline
Percentage of participants in whom preoperative clinical staging correctly predicts the final pathological tumor stage (pT) and lymph node status (pN). Diagnostic performance will also be assessed using sensitivity, specificity, positive predictive value, and negative predictive value, as applicable.
Time frame: Baseline
Percentage of participants in whom preoperative endoscopic ultrasonography correctly predicts the final pathological tumor invasion depth (pT stage) and lymph node status (pN). Diagnostic performance will also be assessed using sensitivity, specificity, positive predictive value, and negative predictive value, as applicable.
Corporacion Parc Tauli
Other
Differences Between Clinical and Pathological Staging in Early Gastric Cancer (EGC): Evaluation of the Potential Impact of Applying Standard and Expanded Asian Endoscopic Resection Criteria in a Western Cohort and Analysis of Disease Progression and Long-Term Survival
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