Diagnostic accuracy of magnetically guided capsule endoscopy with a detachable string for detecting oesophagogastric varices in adults with cirrhosis: prospective multicentre study
Authors: 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 
Published: March 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 (>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
.