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

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Diagnostic accuracy of magnetically guided capsule endoscopy with a detachable string for detecting oesophagogastric varices in adults with cirrhosis: prospective multicentre study
The BMJ ( IF 105.7 ) Pub Date : 2024-03-05 , DOI: 10.1136/bmj-2023-078581
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

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][1]. The steering committee of the CENTERS study will consider reasonable requests for the sharing of deidentified individual participant data. Requests should be made to the corresponding author. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03748563&atom=%2Fbmj%2F384%2Fbmj-2023-078581.atom

更新日期：2024-03-05

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