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北美内镜黏膜下剥离术:一项大型前瞻性多中心研究。

Endoscopic Submucosal Dissection in North America: A Large Prospective Multicenter Study.

机构信息

Division of Gastroenterology and Hepatology, University of Florida, Gainesville, Florida.

Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

出版信息

Gastroenterology. 2021 Jun;160(7):2317-2327.e2. doi: 10.1053/j.gastro.2021.02.036. Epub 2021 Feb 19.

Abstract

BACKGROUND AND AIMS

Endoscopic submucosal dissection (ESD) in Asia has been shown to be superior to endoscopic mucosal resection (EMR) and surgery for the management of selected early gastrointestinal cancers. We aimed to evaluate technical outcomes of ESD in North America.

METHODS

We conducted a multicenter prospective study on ESD across 10 centers in the United States and Canada between April 2016 and April 2020. End points included rates of en bloc resection, R0 resection, curative resection, adverse events, factors associated with failed resection, and recurrence post-R0 resection.

RESULTS

Six hundred and ninety-two patients (median age, 66 years; 57.8% were men) underwent ESD (median lesion size, 40 mm; interquartile range, 25-52 mm) for lesions in the esophagus (n = 181), stomach (n = 101), duodenum (n = 11), colon (n = 211) and rectum (n = 188). En bloc, R0, and curative resection rates were 91.5%, 84.2%, and 78.3%, respectively. Bleeding and perforation were reported in 2.3% and 2.9% of the cases, respectively. Only 1 patient (0.14%) required surgery for adverse events. On multivariable analysis, severe submucosal fibrosis was associated with failed en bloc, R0, and curative resection and higher risk for adverse events. Overall recurrence was 5.8% (31 of 532) at a mean follow-up of 13.3 months (range, 1-60 months).

CONCLUSIONS

In this large multicenter prospective North American experience, we demonstrate that ESD can be performed safely, effectively, and is associated with a low recurrence rate. The technical resection outcomes achieved in this study are in line with the current established consensus quality parameters and further support the implementation of ESD for the treatment of select gastrointestinal neoplasms; ClinicalTrials.gov, Number: NCT02989818.

摘要

背景与目的

内镜黏膜下剥离术(ESD)在亚洲已被证明优于内镜黏膜切除术(EMR)和手术,适用于治疗某些早期胃肠道癌症。我们旨在评估北美 ESD 的技术结果。

方法

我们在美国和加拿大的 10 个中心进行了一项多中心前瞻性 ESD 研究,时间为 2016 年 4 月至 2020 年 4 月。研究终点包括整块切除率、R0 切除率、治愈性切除率、不良事件、与切除失败相关的因素以及 R0 切除后复发率。

结果

692 例患者(中位年龄 66 岁;57.8%为男性)接受了 ESD(中位病变大小 40mm;四分位间距 25-52mm),病变部位分别为食管(n=181)、胃(n=101)、十二指肠(n=11)、结肠(n=211)和直肠(n=188)。整块切除、R0 切除和治愈性切除率分别为 91.5%、84.2%和 78.3%。分别有 2.3%和 2.9%的病例发生出血和穿孔。仅有 1 例(0.14%)患者因不良事件需要手术。多变量分析显示,严重黏膜下纤维化与整块切除、R0 切除和治愈性切除失败以及不良事件风险增加相关。中位随访 13.3 个月(范围 1-60 个月)时,总体复发率为 5.8%(31/532)。

结论

在这项多中心前瞻性北美大型研究中,我们证明 ESD 可以安全、有效地进行,且复发率较低。该研究中实现的技术切除结果与当前既定的质量参数一致,进一步支持 ESD 用于治疗某些胃肠道肿瘤;临床试验注册编号:NCT02989818。

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