| Objective: Endoscopic submucosal dissection(ESD)is one of the main treatment methods for early gastric cancer(EGC).However,some patients do not achieve curative resection after the treatment.The Japanese gastric cancer association(JGCA)guidelines defined non-curative resection of ESD as endoscopic curability(eCura)C resection,which could be further divided into eCura C-1 resection and eCura C-2 resection.The subsequent management after eCura C-2 resection has been controversial,and current studies suggest that it should be performed individually according to the patient’s own condition.In addition,the eCura scoring system,which can facilitate the selection of subsequent management after non-curative ESD remains to be verified in China.This study aims to investigate the clinical outcomes of EGC patients after ESD eCura C-2resection and to validate the eCura scoring system,so as to instruct the subsequent management after eCura C-2 ESD.Methods: EGC patients who have undergone eCura C-2 ESD at the Affiliated Hospital of Qingdao University from May 2013 to March 2021 were retrospectively included.The included patients were divided into surgical group and non-surgical group according to whether additional surgery was immediately performed after ESD.The surgical group was further divided into lymph node metastasis(LNM)positive group and LNM negative group or local residual cancer(LRC)positive group and LRC negative group according to pathological findings.The non-surgical group was further divided into recurrence group and non-recurrence group according to the presence or absence of gastric cancer recurrence.Clinicopathological data such as age,gender,comorbidities,lesion location,circumferential location,macroscopic type,lesion histology,size,depth of invasion,ulcerative findings,margin status,lymphovascular invasion and perineural invasion,as well as follow-up data such as death and gastric cancer recurrence in the surgical and non-surgical groups were collected.The chi-square test or Fisher’s exact test were used to compare the clinicopathological differences between the surgical and non-surgical groups,the Kaplan-Meier method was used to analyze the survival of the two groups,and the Log-Rank test was used to compare the differences in the survival curves of the two groups.Fisher’s exact test and Logistic regression were used to analyze the predictors of LNM or LRC in the surgical group,and Log-Rank test and Cox regression were used to analyze the predictors of gastric cancer recurrence in the non-surgical group.Patients in the surgical group were scored and stratified according to the eCura scoring system,the LNM rates of each risk layers were calculated,and Fisher’s exact test was used to compare the differences of LNM rates between each risk layers.P-value less than 0.05(two-sided)was considered statistically significant.Results: A total of 98 EGC patients in this study met the criteria for ESD eCura C-2resection.Among them,54(55.1%)in the surgical group and 44(44.9%)in the non-surgical group.The proportions of undifferentiated EGC(55.6%,P=0.034)and ulcerative EGC(11.1%,P=0.031)in the surgical group were significantly higher than those in the non-surgical group.The 5-,3-,2-,and 1-year disease-specific survival rates were 100.0% in both the surgical and non-surgical groups.The 5-,3-,2-,and 1-year overall survival rates were 97.6% and 100.0% in the surgical and non-surgical groups,respectively.There was no significant difference in the overall survival curves between the two groups(P=0.406).The 5-,3-,2-,and 1-year disease-free survival rates were100.0% in the surgical group.The 5-,3-,and 2-year disease-free survival rates were90.5% in the non-surgical group,while the 1-year disease-free survival rate was 94.0%.There was a significant difference in the disease-free survival curves between the two groups(P=0.044).In the surgical group,LNM was detected in 5(9.3%)cases,and LRC was detected in 12(22.2%)cases.In univariate analysis,the predictor of LNM was perineural invasion(P=0.039)and the potential predictor of LNM was lymphatic invasion(P=0.084),while predictors of LRC were ulcerative EGC(P=0.018)and positive vertical margin(P=0.012).In multivariate analysis,perineural invasion(OR=12.565,95% CI:1.113～141.850,P=0.041)was the independent predictor of LNM while ulcerative EGC(OR=10.692,95% CI: 1.353～84.493,P=0.025)and positive vertical margin(OR=6.695,95% CI: 1.458～30.736,P=0.014)were independent predictors of LRC.In the non-surgical group,gastric cancer recurrence was observed in 3(6.8%)cases.In univariate analysis,the predictor of gastric cancer recurrence was undifferentiated EGC(P=0.011)and the potential predictor of gastric cancer recurrence was flat or depressed lesion(P=0.076).In multivariate analysis,there was no independent predictor of gastric cancer recurrence.After applying eCura scoring system to the surgical group,LNM rates of the low-,intermediate-,and high-risk layers were 0%(0/30),11.8%(2/17),and 42.9%(3/7),respectively.There was a significant difference in LNM rates between the high-and low-risk layers(P=0.005),while there was no significant difference in LNM rates between the intermediate-and low-risk layers(P=0.126).Conclusions: 1.Additional surgery can significantly reduce the gastric cancer recurrence risk for EGC patients who have undergone eCura C-2 ESD.Patients with undifferentiated EGC or ulcerative EGC are more likely to accept additional surgery after eCura C-2 ESD.2.For EGC patients who have undergone eCura C-2 ESD,perineural invasion was the independent predictor of LNM,ulcerative EGC and positive vertical margin were independent predictors of LRC,while undifferentiated EGC was a significant predictor of gastric cancer recurrence.Patients with perineural invasion,ulcerative EGC,positive vertical margin,or undifferentiated EGC should accept additional surgery after eCura C-2ESD if there was no surgical resistance factors.3.The eCura scoring system showed good LNM risk stratification efficacy when applied to EGC patients who have undergone eCura C-2 ESD,and its application is recommended. |
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