本文由小咖机器人翻译整理

期刊来源：BMJ

原文链接：https://doi.org/10.1136/bmj-2023-078581

摘要内容如下：

客观

评估使用可脱线磁导胶囊内镜（DS-MCE）检测和分级成人肝硬化患者食管胃底静脉曲张的诊断准确性和安全性。

设计

前瞻性多中心诊断准确性研究。

设置

中国有14个医疗中心。

参与者

在2021年1月7日至2022年8月25日期间招募了607名患有肝硬化的成年人（>18岁）。参与者接受了DS-MCE（指数测试），随后在48小时内接受了食管胃十二指肠镜检查（OGD，参考测试）。参与者以2:1的比例分为开发和验证队列。

主要结果指标

主要结果是与OGD相比，DS-MCE检测食管胃静脉曲张的敏感性和特异性。次要转归包括DS-MCE检测高危食管静脉曲张的敏感性和特异性，以及DS-MCE检测高危食管胃静脉曲张、食管静脉曲张和胃静脉曲张的诊断准确性。

结果

在607名参与者中，有582名（95.9%）完成了DS-MCE和OGD检查。以OGD作为参考标准，DS-MCE检测食管胃底静脉曲张的敏感性为97.5%（95%可信区间95.5%-98.7%），特异性为97.8%（94.4%-99.1%）（与预先设定的85%阈值相比，P均<0.001）。当使用来自发育队列（n=393）的食管腔周长的最佳18%阈值时，验证队列（n=189）中DS-MCE检测高危食管静脉曲张的敏感性和特异性分别为95.8%（89.7%-98.4%）和94.7%（88.2%-97.7%）。DS-MCE对高危食管胃底静脉曲张、食管静脉曲张和胃底静脉曲张的诊断准确率分别为96.3%（92.6%-98.2%）、96.9%（95.2%-98.0%）和96.7%（95.0%-97.9%）。OGD发生2例严重不良事件，而DS-MCE未发生严重不良事件。

结论

本研究的结果表明，DS-MCE是一种用于检测和分级食管胃静脉曲张的高度准确和安全的诊断工具，并且是OGD筛查和监测肝硬化患者食管胃静脉曲张的一种很有前途的替代方法。

试用注册

ClinicalTrials.gov NCT03748563。

英文原文如下：

Abstracts

OBJECTIVE  To evaluate the diagnostic accuracy and safety of using magnetically guided capsule endoscopy with a detachable string (ds-MCE) for detecting and grading oesophagogastric varices in adults with cirrhosis.

DESIGN  Prospective multicentre diagnostic accuracy study.

SETTING  14 medical centres in China.

PARTICIPANTS  607 adults (>18 years) with cirrhosis recruited between 7 January 2021 and 25 August 2022. Participants underwent ds-MCE (index test), followed by oesophagogastroduodenoscopy (OGD, reference test) within 48 hours. The participants were divided into development and validation cohorts in a ratio of 2:1.

MAIN OUTCOME MEASURES  The primary outcomes were the sensitivity and specificity of ds-MCE in detecting oesophagogastric varices compared with OGD. Secondary outcomes included the sensitivity and specificity of ds-MCE for detecting high risk oesophageal varices and the diagnostic accuracy of ds-MCE for detecting high risk oesophagogastric varices, oesophageal varices, and gastric varices.

RESULTS  ds-MCE and OGD examinations were completed in 582 (95.9%) of the 607 participants. Using OGD as the reference standard, ds-MCE had a sensitivity of 97.5% (95% confidence interval 95.5% to 98.7%) and specificity of 97.8% (94.4% to 99.1%) for detecting oesophagogastric varices (both P<0.001 compared with a prespecified 85% threshold). When using the optimal 18% threshold for luminal circumference of the oesophagus derived from the development cohort (n=393), the sensitivity and specificity of ds-MCE for detecting high risk oesophageal varices in the validation cohort (n=189) were 95.8% (89.7% to 98.4%) and 94.7% (88.2% to 97.7%), respectively. The diagnostic accuracy of ds-MCE for detecting high risk oesophagogastric varices, oesophageal varices, and gastric varices was 96.3% (92.6% to 98.2%), 96.9% (95.2% to 98.0%), and 96.7% (95.0% to 97.9%), respectively. Two serious adverse events occurred with OGD but none with ds-MCE.

CONCLUSION  The findings of this study suggest that ds-MCE is a highly accurate and safe diagnostic tool for detecting and grading oesophagogastric varices and is a promising alternative to OGD for screening and surveillance of oesophagogastric varices in patients with cirrhosis.

TRIAL REGISTRATION  ClinicalTrials.gov NCT03748563.

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