Clinical Trial

. 2024 Mar 5:384:e078581.

doi: 10.1136/bmj-2023-078581.

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

Xi Jiang¹, Jun Pan¹, Qing Xu², Yu-Hu Song³, Huan-Huan Sun⁴, Cheng Peng⁵, Xiao-Long Qi⁶, Yang-Yang Qian¹, Wen-Bin Zou¹, Yang Yang⁷, Shao-Qin Jin⁸, Ben-Song Duan⁹, Shan Wu¹⁰, Ye Chu¹¹, Ding-Hua Xiao¹², Li-Juan Hu¹³, Jun-Zhi Cao¹⁴, Jin-Feng Dai¹⁵, Xiao Liu¹, Tian Xia¹, Wei Zhou¹, Tao Chen⁹, Chun-Hua Zhou¹¹, Wei Wu¹¹, Shao-Jun Liu¹², Zhen-Yu Yang¹², Fen Wang¹², Lu Zhang¹⁵, Cheng-Zhong Li¹⁶, Hao Xu¹⁶, Jun-Xue Wang¹⁷, Bo Wei¹⁷, Yong Lin¹⁸, Xing Deng¹⁸, Li-Hong Qu¹⁹, Ying-Qiu Shen¹⁹, Hui Wang²⁰, Yi-Fei Huang²¹, Hai-Biao Bao¹⁵, Shuo Zhang²², Li Li¹⁴, Yi-Hai Shi¹³, Xiao-Yan Wang¹², Duo-Wu Zou¹¹, Xin-Jian Wan¹⁰, Mei-Dong Xu⁹, Hua Mao⁸, Chao-Hui He⁷, Zhen Li⁵, Xiu-Li Zuo⁵, Shui-Xiang He⁴, Xiao-Ping Xie³, Jun Liu³, Chang-Qing Yang², Cristiano Spada²³, Zhao-Shen Li¹, Zhuan Liao²⁴

Affiliations

¹ 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.
² Department of Gastroenterology and Hepatology, Tongji Hospital of Tongji University School of Medicine, Shanghai, China.
³ Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
⁴ Department of Gastroenterology, Shanxi Clinical Research Centre of Digestive Disease (cancer division), the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
⁵ Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.
⁶ 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.
⁷ Department of Gastroenterology and Endoscopy, The Fifth affiliated Zhuhai Hospital of Zunyi Medical University, Zhuhai, China.
⁸ Department of Gastroenterology, Zhujiang Hospital, Southern Medical University, Guangzhou, China.
⁹ Department of Gastroenterology, Endoscopy Centre, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.
¹⁰ Department of Endoscopy, The Sixth People's Hospital, Shanghai Jiao Tong University, Shanghai, China.
¹¹ Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao Tong 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 Area Gongli Hospital, Shanghai, China.
¹⁴ Department of Gastroenterology, Yangpu Hospital, Tongji University, Shanghai, China.
¹⁵ Department of Gastroenterology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.
¹⁶ Department of Infectious Diseases, Changhai Hospital, Naval Medical University, Shanghai, China.
¹⁷ Department of Infection, Changzheng Hospital, Naval Medical University, Shanghai, China.
¹⁸ Department of Gastroenterology, Changzheng Hospital, Naval Medical University, Shanghai, China.
¹⁹ Department of Infectious Diseases, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.
²⁰ Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
²¹ Department of Gastroenterology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
²² Department of Gastroenterology, The Second Affiliated Hospital of Zhejiang Chinese University, Hangzhou, China.
²³ Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
²⁴ 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 liaozhuan@smmu.edu.cn.

PMID: 38443074
PMCID: PMC10912951
DOI: 10.1136/bmj-2023-078581

Clinical Trial

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

Xi Jiang et al. BMJ. 2024.

. 2024 Mar 5:384:e078581.

doi: 10.1136/bmj-2023-078581.

Authors

Affiliations

¹ 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.
² Department of Gastroenterology and Hepatology, Tongji Hospital of Tongji University School of Medicine, Shanghai, China.
³ Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
⁴ Department of Gastroenterology, Shanxi Clinical Research Centre of Digestive Disease (cancer division), the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
⁵ Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.
⁶ 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.
⁷ Department of Gastroenterology and Endoscopy, The Fifth affiliated Zhuhai Hospital of Zunyi Medical University, Zhuhai, China.
⁸ Department of Gastroenterology, Zhujiang Hospital, Southern Medical University, Guangzhou, China.
⁹ Department of Gastroenterology, Endoscopy Centre, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.
¹⁰ Department of Endoscopy, The Sixth People's Hospital, Shanghai Jiao Tong University, Shanghai, China.
¹¹ Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao Tong 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 Area Gongli Hospital, Shanghai, China.
¹⁴ Department of Gastroenterology, Yangpu Hospital, Tongji University, Shanghai, China.
¹⁵ Department of Gastroenterology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.
¹⁶ Department of Infectious Diseases, Changhai Hospital, Naval Medical University, Shanghai, China.
¹⁷ Department of Infection, Changzheng Hospital, Naval Medical University, Shanghai, China.
¹⁸ Department of Gastroenterology, Changzheng Hospital, Naval Medical University, Shanghai, China.
¹⁹ Department of Infectious Diseases, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.
²⁰ Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
²¹ Department of Gastroenterology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
²² Department of Gastroenterology, The Second Affiliated Hospital of Zhejiang Chinese University, Hangzhou, China.
²³ Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
²⁴ 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 liaozhuan@smmu.edu.cn.

PMID: 38443074
PMCID: PMC10912951
DOI: 10.1136/bmj-2023-078581

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.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the “Ten Thousand Plan”-National High-Level Talents Special Support Plan and Shanghai Municipal Hospital Emerging Frontier Technology Joint Project for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

**Fig 1**
Magnetically guided capsule endoscopy with a detachable string (ds-MCE). During examination of the oesophagus, the capsule is controlled by a hollow latex string (A); after completion of the oesophageal examination, the string is separated from the capsule by injecting 5 mL of air through the syringe and then removed via the mouth, and the capsule enters the stomach (B); the capsule is then controlled by an external magnetic field during gastric examination (C); then is moved passively under gastrointestinal peristalsis during examination of the small bowel (D)

**Fig 2**
Flow of participants through study. ds-MCE=magnetically guided capsule endoscopy with a detachable string; OGD=oesophagogastroduodenoscopy

**Fig 3**
Representative oesophagogastric varices observed in patients A-F while standing for ds-MCE (panel 1) and OGD (panel 2). Small oesophageal varices (patient A), small oesophageal varices with red colour signs (patient B), large oesophageal varices (patient C), large oesophageal varices with red colour signs (patient D), gastric varices (patient E), and portal hypertensive gastropathy (patient F). ds-MCE=magnetically guided capsule endoscopy with detachable string; OGD=oesophagogastroduodenoscopy

See this image and copyright information in PMC

Comment in

Novel capsule endoscopy for detecting varices.
Njei B, Al-Ajlouni YA, McCarty TR. Njei B, et al. BMJ. 2024 Mar 5;384:q506. doi: 10.1136/bmj.q506. BMJ. 2024. PMID: 38443073 No abstract available.

References

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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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

Comment in

References

Publication types

MeSH terms

Associated data

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Medical