早期胃癌内镜黏膜下剥离术后eCura危险评分系统的临床验证研究

目的验证早期胃癌内镜黏膜下剥离术（endoscopic submucosal dissection,ESD）非治愈性切除术后淋巴结转移风险评估系统——“eCura system”的临床适用性。方法2012年1月—2018年3月,因早期胃癌在南京大学医学院附属南京鼓楼医院行ESD治疗,且术后病理提示ESD非治愈性切除的155例病例被纳入回顾性分析,根据eCura评分系统对病例进行评分,按评分结果分成3组,低危组（0～1分）100例、中危组（2～4分）46例、高危组（5～7分）9例,观察各组随访期内淋巴结转移情况及预后。结果155例随访时间（25±15.0）个月,其中低危组中位随访25个月,中危组中位随访23个月,高危组中位随访34个月。低危组追加外科手术57例,其中3例5.26%（3/57）]淋巴结转移;中危组追加外科手术29例,其中2例6.90%（2/29）]淋巴结转移;高危组9例,均追加外科手术,4例淋巴结转移。多因素Logistic回归分析提示高危组淋巴结转移风险明显高于低危组(P=0.003,OR=14.499,95%CI：2.513～97.214),而中危组淋巴结转移风险较低危组略高(P=0.767,OR=1.326,95%CI：0.165～8.594)。随访过程中,低危组无远处转移及肿瘤相关死亡,43例未追加外科手术者中发现3例6.98%（3/43）]复发。中危组17例未追加外科手术者中发现1例5.88%（1/17）]复发,2例11.76%（2/17）]远处转移,其中1例5.88%（1/17）]死于脑转移;29例追加外科手术者在随访期间无复发、远处转移及肿瘤相关死亡。高危组9例在ESD术后均追加了外科手术,随访期间无复发、远处转移及肿瘤相关死亡。结论eCura评分系统可用于早期胃癌ESD非治愈性切除病例的淋巴结转移风险预测,低危患者追加外科手术的获益有限,而中、高危患者追加外科手术可有效改善预后。

Clinical validation of eCura risk scoring system after endoscopic submucosal dissection for early gastric cancer

ObjectiveTo verify the clinical applicability of "eCura system", a scoring system for assessing the risk of lymph node metastasis after non-curative endoscopic submucosal dissection (ESD) for early gastric cancer (EGC). MethodsA retrospective analysis was performed on clinicopathological data of 155 patients with EGC, who underwent non-curative ESD confirmed by postoperative pathology in Drum Tower Hospital Affiliated to Medical School of Nanjing University from January 2012 to March 2018. According to the eCura scoring system, the 155 patients were divided to three groups: 100 cases in the low-risk group (0 to 1 point), 46 cases in the intermediate-risk group (2 to 4 points), and 9 cases in the high-risk group (5 to 7 points). Lymph node metastasis rates and prognosis of the three groups were observed and compared. ResultsThe follow-up time of the 155 patients was 25±15.0 months, of which median follow-up time was 25 months in the low-risk group, 23 months in the intermediate-risk group, and 34 months in the high-risk group. A total of 57 patients underwent additional surgery in the low-risk group, including 3 cases 5.26% (3/57)] of lymph node metastases; 29 patients underwent additional surgery in the intermediate-risk group, including 2 cases 6.90% (2/29)] of lymph node metastases; all 9 patients in the high-risk group underwent additional surgery and 4 cases had lymph node metastasis. Multivariate Logistic regression analysis showed that the risk of lymph node metastasis in the high-risk group was significantly higher than that in the low-risk group (P=0.003, OR=14.499, 95%CI: 2.513-97.214), while the risk of lymph node metastasis in the intermediate-risk group was slightly higher than that in the low-risk group (P=0.767, OR=1.326, 95%CI: 0.165-8.594). During follow-up, there was no metastasis or cancer-specific mortality in the low-risk group, and recurrence was found in 3 cases 6.98% (3/43)] of the 43 patients without additional surgery. Among the 17 patients in the intermediate-risk group, who did not undergo additional surgery, 1 case 5.88% (1/17)] had recurrence and 2 cases 11.76% (2/17)] had metastasis including 1 case 5.88% (1/17)] died of brain metastasis. There was no recurrence, metastasis or cancer-specific mortality in 29 patients in the intermediate-risk group, who underwent additional surgery during follow-up. And there was no recurrence, metastasis or cancer-specific mortality in the all 9 patients in the high-risk group received additional surgery after ESD during follow-up. ConclusionThe eCura scoring system could contribute to predict the lymph node metastasis risk in patients after non-curative ESD for EGC. The benefits of additional surgery are limited for low-risk patients, while for intermediate-risk and high-risk patients, additional surgery can effectively improve prognosis.