Detachable string magnetically controlled capsule endoscopy for detecting high-risk varices in compensated advanced chronic liver disease (CHESS1801): A prospective multicenter study

Shuai Wang; Yifei Huang; Weiling Hu; Hua Mao; Mark Edward McAlindon; Yanna Liu; Li Yang; Chunqing Zhang; Ming Xu; Chaohui He; Tong Dang; Bin Wu; Dong Ji; Liting Zhang; Xiaorong Mao; Lei Zhang; Chuan Liu; Dan Xu; Yasong Li; Guoan Li; Juqiang Han; Fangfang Lv; Xiao Liang; Shaoqin Jin; Shaoheng Zhang; Foong Way David Tai; Qing Xu; Changqing Yang; Guangchuan Wang; Lifen Wang; Bo Li; Haiyun Yang; Ping Xie; Lulin Deng; Limei Ren; Zhiheng Chang; Xing Wang; Shan Wang; Xiaoqin Gao; Junfeng Li; Longdong Zhu; Fangzhao Wang; Lingen Zhang; Guo Zhang; Xi Jiang; Jun Pan; Wenbo Meng; Xun Li; Jinlin Hou; Xavier Dray; Zhuan Liao; Xiaolong Qi

doi:10.1016/j.lanwpc.2020.100072

Detachable string magnetically controlled capsule endoscopy for detecting high-risk varices in compensated advanced chronic liver disease (CHESS1801): A prospective multicenter study

Lancet Reg Health West Pac. 2020 Dec 11:6:100072. doi: 10.1016/j.lanwpc.2020.100072. eCollection 2021 Jan.

Authors

Shuai Wang¹, Yifei Huang^{2

3}, Weiling Hu⁴, Hua Mao³, Mark Edward McAlindon⁵, Yanna Liu², Li Yang⁶, Chunqing Zhang⁷, Ming Xu⁸, Chaohui He⁹, Tong Dang¹⁰, Bin Wu¹¹, Dong Ji¹, Liting Zhang¹², Xiaorong Mao¹³, Lei Zhang¹⁴, Chuan Liu², Dan Xu², Yasong Li¹⁵, Guoan Li¹⁵, Juqiang Han¹⁵, Fangfang Lv¹⁶, Xiao Liang¹⁷, Shaoqin Jin³, Shaoheng Zhang³, Foong Way David Tai⁵, Qing Xu⁶, Changqing Yang⁶, Guangchuan Wang⁷, Lifen Wang⁷, Bo Li⁸, Haiyun Yang⁸, Ping Xie⁹, Lulin Deng⁹, Limei Ren¹⁰, Zhiheng Chang¹⁰, Xing Wang¹¹, Shan Wang¹², Xiaoqin Gao¹², Junfeng Li¹³, Longdong Zhu¹³, Fangzhao Wang¹⁴, Lingen Zhang¹⁴, Guo Zhang¹⁸, Xi Jiang¹⁹, Jun Pan¹⁹, Wenbo Meng²⁰, Xun Li²⁰, Jinlin Hou²¹, Xavier Dray²², Zhuan Liao¹⁹, Xiaolong Qi²

Affiliations

¹ CHESS Center, Department of Liver Diseases, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China.
² CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, China.
³ Department of Gastroenterology, Zhujiang Hospital, Southern Medical University, Guangzhou, China.
⁴ Department of Gastroenterology, Sir Run Run Shaw Hospital, Medical School; Institute of Gastroenterology, Zhejiang University, Hangzhou, China.
⁵ Academic Department of Gastroenterology and Hepatology, Sheffield Teaching Hospitals NHS Trust, Sheffield, UK.
⁶ Division of Gastroenterology and Hepatology, Digestive Disease Institute, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai, China.
⁷ Department of Gastroenterology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China.
⁸ Department of Gastroenterology, Guangdong Second Provincial General Hospital, Guangzhou, China.
⁹ Department of Gastroenterology, The Fifth Affiliated Hospital of Zunyi Medical University, Zhuhai, China.
¹⁰ Department of Gastroenterology, The Second Affiliated Hospital of Baotou Medical College, Baotou, China.
¹¹ Department of Gastroenterology, Third Affiliated Hospital of Sun Yat-sen University, Guangdong Province Engineering and Technology Research Center of Digestive Endoscopy, Guangzhou, China.
¹² Department of Hepatology, The First Hospital of Lanzhou University, Lanzhou, China.
¹³ Department of Infectious Diseases, The First Hospital of Lanzhou University, Lanzhou, China.
¹⁴ Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China.
¹⁵ Department of Liver Diseases, the Seventh Medical Center, Chinese PLA General Hospital, Beijing, China.
¹⁶ Department of Infectious Diseases, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
¹⁷ Department of General Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
¹⁸ Department of Gastroenterology, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, China.
¹⁹ National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Shanghai, China.
²⁰ The First Hospital of Lanzhou University, Lanzhou, China.
²¹ Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China.
²² Sorbonne University, Centre for Digestive Endoscopy, Saint Antoine Hospital, APHP, Paris, France.

Abstract

Background: Gastroesophageal varices is a serious complication of compensated advanced chronic liver disease (cACLD). Primary prophylaxis to reduce the risk of variceal hemorrhage is recommended if high-risk varices (HRV) are detected. We performed this study to compare the accuracy, patients' satisfaction and safety of detection of HRV by detachable string magnetically controlled capsule endoscopy (DS-MCCE) with esophagogastroduodenoscopy (EGD) as the reference.

Methods: We prospectively recruited participants with cACLD from 12 university hospitals (11 in China and one in the United Kingdom) between November 2018 and December 2019 (ClinicalTrials.gov, NCT03749954). All participants underwent DS-MCCE, followed by EGD within a week in a blinded fashion. Following endoscopy, and on the same day, participants were asked to fill in a satisfaction questionnaire regarding their experience.

Findings: A total of 105 eligible participants were enrolled. With EGD as the reference standard, the concordance index, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio of DS-MCCE in diagnosis of HRV were 0•90 (95% confidence interval [CI]: 0•83-0•95), 92% (95% CI: 78-98%), 88% (95% CI: 78-95%), 80% (95% CI: 70-92%), 95% (95% CI: 90-100%), 7•91 (95% CI: 4•10-15•30), and 0•09 (95% CI: 0•03-0•30), respectively. The kappa score of 0•78 (95% CI: 0•65-0•90) suggested substantial agreement between DS-MCCE and EGD. Moreover, in participants undergoing EGD without sedation, the satisfaction of DS-MCCE was significantly better than that of EGD (p < 0•0001, d = 1•15 [95%CI: 0•88-1•42]). All participants confirmed the excretion of the capsule, and no adverse events occurred.

Interpretation: DS-MCCE is an accurate alternative to EGD for detecting HRV in cACLD, which is safe and associated with better satisfaction.

Funding: A full list of funding can be found in the Funding Support section.

Keywords: Clinical trial; Esophagogastroduodenoscopy; Gastroesophageal varices; Portal hypertension; Prospective.

Associated data

ClinicalTrials.gov/NCT03749954