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 93.6 ) Pub Date : 2024-03-05 , DOI: 10.1136/bmj-2023-078581
Xi Jiang ₁ , Jun Pan ₁ , Qing Xu ₂ , Yu-Hu Song ₃ , Huan-Huan Sun ₄ , Cheng Peng ₅ , Xiao-Long Qi ₆ , Yang-Yang Qian ₁ , Wen-Bin Zou ₁ , Yang Yang ₇ , Shao-Qin Jin ₈ , Ben-Song Duan ₉ , Shan Wu ₁₀ , Ye Chu ₁₁ , Ding-Hua Xiao ₁₂ , Li-Juan Hu ₁₃ , Jun-Zhi Cao ₁₄ , Jin-Feng Dai ₁₅ , Xiao Liu ₁ , Tian Xia ₁ , Wei Zhou ₁ , Tao Chen ₉ , Chun-Hua Zhou ₁₁ , Wei Wu ₁₁ , Shao-Jun Liu ₁₂ , Zhen-Yu Yang ₁₂ , Fen Wang ₁₂ , Lu Zhang ₁₅ , Cheng-Zhong Li ₁₆ , Hao Xu ₁₆ , Jun-Xue Wang ₁₇ , Bo Wei ₁₇ , Yong Lin ₁₈ , Xing Deng ₁₈ , Li-Hong Qu ₁₉ , Ying-Qiu Shen ₁₉ , Hui Wang ₂₀ , Yi-Fei Huang ₂₁ , Hai-Biao Bao ₁₅ , Shuo Zhang ₂₂ , Li Li ₁₄ , Yi-Hai Shi ₁₃ , Xiao-Yan Wang ₁₂ , Duo-Wu Zou ₁₁ , Xin-Jian Wan ₁₀ , Mei-Dong Xu ₉ , Hua Mao ₈ , Chao-Hui He ₇ , Zhen Li ₅ , Xiu-Li Zuo ₅ , Shui-Xiang He ₄ , Xiao-Ping Xie ₃ , Jun Liu ₃ , Chang-Qing Yang ₂ , Cristiano Spada ₂₃ , Zhao-Shen Li ₁ , Zhuan Liao ₂₄

Affiliation

Department of Gastroenterology, Changhai Clinical Research Unit, National Clinical Research Centre for Digestive Diseases, National Key Laboratory of Immunity and Inflammation, Changhai Hospital, Naval Medical University, Shanghai 200433, China.
Department of Gastroenterology and Hepatology, Tongji Hospital of Tongji University School of Medicine, Shanghai, China.
Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Department of Gastroenterology, Shanxi Clinical Research Centre of Digestive Disease (cancer division), the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.
CHESS Centre, Department of Radiology, Basic Medicine Research and Innovation Centre of Ministry of Education, Zhongda Hospital, Medical School, Southeast University, Nurturing Centre of Jiangsu Province for State Laboratory of AI Imaging and Interventional Radiology, Nanjing, China.
Department of Gastroenterology and Endoscopy, The Fifth affiliated Zhuhai Hospital of Zunyi Medical University, Zhuhai, China.
Department of Gastroenterology, Zhujiang Hospital, Southern Medical University, Guangzhou, China.
Department of Gastroenterology, Endoscopy Centre, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.
Department of Endoscopy, The Sixth People's Hospital, Shanghai Jiao Tong University, Shanghai, China.
Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Department of Gastroenterology, The Third Xiangya Hospital, Central South University, Changsha, China.
Department of Gastroenterology, Shanghai Pudong New Area Gongli Hospital, Shanghai, China.
Department of Gastroenterology, Yangpu Hospital, Tongji University, Shanghai, China.
Department of Gastroenterology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.
Department of Infectious Diseases, Changhai Hospital, Naval Medical University, Shanghai, China.
Department of Infection, Changzheng Hospital, Naval Medical University, Shanghai, China.
Department of Gastroenterology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Department of Infectious Diseases, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.
Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Department of Gastroenterology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
Department of Gastroenterology, The Second Affiliated Hospital of Zhejiang Chinese University, Hangzhou, China.
Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
Department of Gastroenterology, Changhai Clinical Research Unit, National Clinical Research Centre for Digestive Diseases, National Key Laboratory of Immunity and Inflammation, Changhai Hospital, Naval Medical University, Shanghai 200433, China

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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