Diagnostic accuracy of magnetically guided capsule endoscopy with a detachable string for detecting oesophagogastric varices in adults with cirrhosis: prospective multicentre study
Authors: 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
Journal: BMJ (2024)

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 (&gt;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&lt;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 .