长海医院廖专团队研究了磁导胶囊内镜（ds-MCE）诊断消化道疾病的准确性。相关论文于2024年3月5日发表在《英国医学杂志》上。

为了评估可拆卸式磁导胶囊内镜（ds-MCE）诊断和分级成人肝硬化食管胃底静脉曲张的准确性和安全性，研究组在中国的14个医疗中心进行了一项前瞻性多中心诊断准确性研究。2021年1月7日至2022年8月25日期间，共招募了607名患有肝硬化的成年人（>18岁）。参与者在48小时内接受了ds-MCE（指标测试），然后进行了食道胃十二指肠镜检查（OGD，参考测试）。参与者按2:1的比例被分为开发组和验证组。主要结局是与OGD相比，ds-MCE检测食管胃底静脉曲张的敏感性和特异性。次要结局包括ds-MCE检测高危食管静脉曲张的敏感性和特异性，以及ds-MCE诊断高危食管-胃静脉曲张、食管静脉曲张和胃静脉曲张的准确性。

607名参与者中582名（95.9%）完成了ds MCE和OGD检查。以OGD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%置信区间95.5%-98.7%），特异性为97.8%（94.4%-99.1%）（与预先指定的85%阈值相比，两者均<0.001）。当使用来自开发队列（n=393）的食管管腔周长的最佳18%阈值时，在验证队列（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%至98.4%）和94.7%（88.2%至97.7%）。ds-MCE对高危食管胃底静脉曲张、食管静脉曲张和胃静脉曲张的诊断准确率分别为96.3%（92.6%至98.2%）、96.9%（95.2%至98.0%）和96.7%（95.0%至97.9%）。OGD发生两例严重不良事件，但ds-MCE无一例发生。

这项研究结果表明，ds-MCE是一种高度准确和安全的检测和分级食管胃底静脉曲张的诊断工具，是筛查和监测肝硬化患者食管胃底静脉曲张的一种很有前途的替代OGD的方法。

附：英文原文

Title: Diagnostic accuracy of magnetically guided capsule endoscopy with a detachable string for detecting oesophagogastric varices in adults with cirrhosis: prospective multicentre study

Author: Xi Jiang, Jun Pan, Qing Xu, Yu-Hu Song, Huan-Huan Sun, Cheng Peng, Xiao-Long Qi, Yang-Yang Qian, Wen-Bin Zou, Yang Yang, Shao-Qin Jin, Ben-Song Duan, Shan Wu, Ye Chu, Ding-Hua Xiao, Li-Juan Hu, Jun-Zhi Cao, Jin-Feng Dai, Xiao Liu, Tian Xia, Wei Zhou, Tao Chen, Chun-Hua Zhou, Wei Wu, Shao-Jun Liu, Zhen-Yu Yang, Fen Wang, Lu Zhang, Cheng-Zhong Li, Hao Xu, Jun-Xue Wang, Bo Wei, Yong Lin, Xing Deng, Li-Hong Qu, Ying-Qiu Shen, Hui Wang, Yi-Fei Huang, Hai-Biao Bao, Shuo Zhang, Li Li, Yi-Hai Shi, Xiao-Yan Wang, Duo-Wu Zou, Xin-Jian Wan, Mei-Dong Xu, Hua Mao, Chao-Hui He, Zhen Li, Xiu-Li Zuo, Shui-Xiang He, Xiao-Ping Xie, Jun Liu, Chang-Qing Yang, Cristiano Spada, Zhao-Shen Li, Zhuan Liao

Issue&Volume: 2024/03/05

Abstract:

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.

DOI: 10.1136/bmj-2023-078581

Source: https://www.bmj.com/content/384/bmj-2023-078581