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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

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单位: [1]Department of Gastroenterology, Changhai Clinical Research Unit,National Clinical Research Centre for Digestive Diseases, NationalKey Laboratory of Immunity and Inflammation, Changhai Hospital,Naval Medical University, Shanghai 200433, China [2]Department of Gastroenterology and Hepatology, Tongji Hospitalof Tongji University School of Medicine, Shanghai, China [3]Department of Gastroenterology, Union Hospital, Tongji MedicalCollege, Huazhong University of Science and Technology, Wuhan,China [4]Department of Gastroenterology, Shanxi Clinical Research Centreof Digestive Disease (cancer division), the First Affiliated Hospital ofXi’an Jiaotong University, Xi’an, China [5]Department of Gastroenterology, Qilu Hospital, Cheeloo College ofMedicine, Shandong University, Jinan, China [6]CHESS Centre, Department of Radiology, Basic Medicine Researchand Innovation Centre of Ministry of Education, Zhongda Hospital,Medical School, Southeast University, Nurturing Centre of JiangsuProvince for State Laboratory of AI Imaging and InterventionalRadiology, Nanjing, China [7]Department of Gastroenterology and Endoscopy, The Fifth affiliatedZhuhai Hospital of Zunyi Medical University, Zhuhai, China [8]Department of Gastroenterology, Zhujiang Hospital, SouthernMedical University, Guangzhou, China [9]Department of Gastroenterology, Endoscopy Centre, Shanghai EastHospital, Tongji University School of Medicine, Shanghai, China [10]Department of Endoscopy, The Sixth People’s Hospital, ShanghaiJiao Tong University, Shanghai, China [11]Department of Gastroenterology, Ruijin Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China [12]Department of Gastroenterology, The Third Xiangya Hospital,Central South University, Changsha, China [13]Department of Gastroenterology, Shanghai Pudong New AreaGongli Hospital, Shanghai, China [14]Department of Gastroenterology, Yangpu Hospital, TongjiUniversity, Shanghai, China [15]Department of Gastroenterology, The First Affiliated Hospital ofZhejiang Chinese Medical University, Hangzhou, China [16]Department of Infectious Diseases, Changhai Hospital, NavalMedical University, Shanghai, China [17]Department of Infection, Changzheng Hospital, Naval MedicalUniversity, Shanghai, China [18]Department of Gastroenterology, Changzheng Hospital, NavalMedical University, Shanghai, China [19]Department of Infectious Diseases, Shanghai East Hospital, TongjiUniversity School of Medicine, Shanghai, China [20]Department of Infectious Diseases, Ruijin Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China [21]Department of Gastroenterology, The Third Affiliated Hospital ofSun Yat-sen University, Guangzhou, China [22]Department of Gastroenterology, The Second Affiliated Hospital ofZhejiang Chinese University, Hangzhou, China [23]Digestive Endoscopy Unit, Fondazione Policlinico UniversitarioAgostino Gemelli IRCCS, Rome, Italy
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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.Prospective multicentre diagnostic accuracy study.14 medical centres in China.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.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.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.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.ClinicalTrials.gov NCT03748563.© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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出版当年[2023]版:
大类 | 1 区 医学
小类 | 1 区 医学:内科
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大类 | 1 区 医学
小类 | 1 区 医学:内科
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Q1 MEDICINE, GENERAL & INTERNAL
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Q1 MEDICINE, GENERAL & INTERNAL

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第一作者单位: [1]Department of Gastroenterology, Changhai Clinical Research Unit,National Clinical Research Centre for Digestive Diseases, NationalKey Laboratory of Immunity and Inflammation, Changhai Hospital,Naval Medical University, Shanghai 200433, China
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