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Jiang, Xi; Pan, Jun; Xu, Qing; Song, Yu-Hu; Sun, Huan-Huan; Peng, Cheng; Qi, Xiao-Long; Qian, Yang-Yang; Zou, Wen-Bin; Yang, Yang; Jin, Shao-Qin; Duan, Ben-Song; Wu, Shan; Chu, Ye; Xiao, Ding-Hua; Hu, Li-Juan; Cao, Jun-Zhi; Dai, Jin-Feng; Liu, Xiao; Xia, Tian; Zhou, Wei; Chen, Tao; Zhou, Chun-Hua; Wu, Wei; Liu, Shao-Jun; Yang, Zhen-Yu; Wang, Fen; Zhang, Lu; Li, Cheng-Zhong; Xu, Hao; Wang, Jun-Xue; Wei, Bo; Lin, Yong; Deng, Xing; Qu, Li-Hong; Shen, Ying-Qiu; Wang, Hui; Huang, Yi-Fei; Bao, Hai-Biao; Zhang, Shuo; Li, Li; Shi, Yi-Hai; Wang, Xiao-Yan; Zou, Duo-Wu; Wan, Xin-Jian; Xu, Mei-Dong; Mao, Hua; He, Chao-Hui; Li, Zhen; Zuo, Xiu-Li; He, Shui-Xiang; Xie, Xiao-Ping; Liu, Jun; Yang, Chang-Qing; Spada, Cristiano; Li, Zhao-Shen; Liao, Zhuan
BMJ (Online), 03/2024, Volume: 384Journal Article
AbstractObjectiveTo 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.DesignProspective multicentre diagnostic accuracy study.Setting14 medical centres in China.Participants607 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 measuresThe 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.Resultsds-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.ConclusionThe 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 registrationClinicalTrials.gov NCT03748563.
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