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食管黏膜下隧道内镜切除术相关不良事件的词汇景观:一项大样本量(1701 例)研究。

Landscape of esophageal submucosal tunneling endoscopic resection-related adverse events in a standardized lexicon: a large volume of 1701 cases.

机构信息

Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai, China.

出版信息

Surg Endosc. 2022 Nov;36(11):8112-8120. doi: 10.1007/s00464-022-09241-7. Epub 2022 Apr 25.

DOI:10.1007/s00464-022-09241-7
PMID:35467145
Abstract

BACKGROUND

Submucosal tunneling endoscopic resection (STER) has been widely applied for esophageal submucosal tumors. This large volume study aims to provide a standard landscape of STER-related AEs for reference.

METHODS

1701 patients with esophageal SMTs undergoing STER were included at Zhongshan Hospital, Fudan University. Data of clinical characteristics and adverse events were collected and analyzed in depth. Adverse events were recorded by ASGE lexicon and graded by ASGE grading/Clavien-Dindo system. Risk factors for major AEs were analyzed by univariate and multivariate logistic regression.

RESULTS

Three hundred and twenty (18.8%) patients with 962 cases of adverse events were observed. Accordingly, 84 (5.0%) were classified as major AEs (moderate and severe) by ASGE grading and 37 (2.2%) were classified as major AEs (grades III-V) by Clavien-Dindo grading. First 1 year operation, distance > 6 cm from incision to tumor, piecemeal resection, partially extraluminal location, mucosal injury, and operation time > 60 min were included in the risk score model for major AEs of STER, with 57.1% sensitivity and 87.5% specificity.

CONCLUSIONS

STER was a safe procedure for diagnosis and treatment of esophageal SMTs with a total 18.8% incidence of AEs, among which only 5.0% were major AEs requiring therapeutic measurements.

摘要

背景

黏膜下隧道内镜切除术(STER)已广泛应用于食管黏膜下肿瘤。本大量研究旨在为STER 相关不良事件提供一个标准的概述。

方法

在复旦大学中山医院,共纳入 1701 例接受食管 SMTs 行 STER 的患者。深入收集和分析了患者的临床特征和不良事件数据。不良事件采用 ASGE 词汇表记录,并采用 ASGE 分级/Clavien-Dindo 系统进行分级。采用单因素和多因素逻辑回归分析主要不良事件的危险因素。

结果

观察到 320 例(18.8%)患者发生 962 例不良事件。因此,84 例(5.0%)按 ASGE 分级为主要不良事件(中重度),37 例(2.2%)按 Clavien-Dindo 分级为主要不良事件(III-V 级)。首次 1 年手术、切口至肿瘤距离>6cm、分片切除、部分腔外位置、黏膜损伤和手术时间>60min 纳入 STER 主要不良事件风险评分模型,其敏感性为 57.1%,特异性为 87.5%。

结论

STER 是一种安全的诊断和治疗食管 SMTs 的方法,其不良事件总发生率为 18.8%,其中仅 5.0%需要治疗措施的主要不良事件。

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