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欧洲内镜黏膜下剥离术:德国内镜黏膜下剥离术登记研究中 1000 例肿瘤性病变的结果。

Endoscopic Submucosal Dissection in Europe: Results of 1000 Neoplastic Lesions From the German Endoscopic Submucosal Dissection Registry.

机构信息

Department of Gastroenterology, University Hospital Augsburg, Augsburg, Germany.

Department of Gastroenterology, Sana Klinikum Lichtenberg, Berlin, Germany.

出版信息

Gastroenterology. 2021 Oct;161(4):1168-1178. doi: 10.1053/j.gastro.2021.06.049. Epub 2021 Jun 26.

Abstract

BACKGROUND AND AIMS

Endoscopic submucosal dissection (ESD) enables the curative resection of early malignant lesions and is associated with reduced recurrence risk. Due to the lack of comprehensive ESD data in the West, the German ESD registry was set up to evaluate relevant outcomes of ESD.

METHODS

The German ESD registry is a prospective uncontrolled multicenter study. During a 35-month period, 20 centers included 1000 ESDs of neoplastic lesions. The results were evaluated in terms of en bloc, R0, curative resection rates, and recurrence rate after a 3-month and 12-month follow-up. Additionally, participating centers were grouped into low-volume (≤20 ESDs/y), middle-volume (20-50/y), and high-volume centers (>50/y). A multivariate analysis investigating risk factors for noncurative resection was performed.

RESULTS

Overall, en bloc, R0, and curative resection rates of 92.4% (95% confidence interval [CI], 0.90-0.94), 78.8% (95% CI, 0.76-0.81), and 72.3% (95% CI, 0.69-0.75) were achieved, respectively. The overall complication rate was 8.3% (95% CI, 0.067-0.102), whereas the recurrence rate after 12 months was 2.1%. High-volume centers had significantly higher en bloc, R0, curative resection rates, and recurrence rates and lower complication rates than middle- or low-volume centers. The lesion size, hybrid ESD, age, stage T1b carcinoma, and treatment outside high-volume centers were identified as risk factors for noncurative ESD.

CONCLUSION

In Germany, ESD achieves excellent en bloc resection rates but only modest curative resection rates. ESD requires a high level of expertise, and results vary significantly depending on the center's yearly case volume.

摘要

背景和目的

内镜黏膜下剥离术(ESD)能够实现早期恶性病变的根治性切除,并且降低复发风险。由于西方缺乏全面的 ESD 数据,因此建立了德国 ESD 登记处来评估 ESD 的相关结果。

方法

德国 ESD 登记处是一项前瞻性、非对照的多中心研究。在 35 个月的时间内,20 个中心纳入了 1000 例肿瘤性病变的 ESD。根据整块切除率、R0 切除率、根治性切除率以及 3 个月和 12 个月随访后的复发率来评估结果。此外,将参与中心分为低容量(≤20 例/年)、中容量(20-50 例/年)和高容量(>50 例/年)中心。进行了多变量分析,以调查非根治性切除的危险因素。

结果

总体而言,整块切除率、R0 切除率和根治性切除率分别为 92.4%(95%置信区间[CI],0.90-0.94)、78.8%(95% CI,0.76-0.81)和 72.3%(95% CI,0.69-0.75)。总体并发症发生率为 8.3%(95% CI,0.067-0.102),而 12 个月后的复发率为 2.1%。高容量中心的整块切除率、R0 切除率、根治性切除率和复发率显著高于中容量或低容量中心,而并发症发生率则较低。病变大小、混合型 ESD、年龄、T1b 期癌和在高容量中心以外进行治疗被确定为非根治性 ESD 的危险因素。

结论

在德国,ESD 实现了出色的整块切除率,但仅获得了中等水平的根治性切除率。ESD 需要高水平的专业知识,并且结果因中心的年手术量而有显著差异。

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