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, 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

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.

Conflict of interest statement

The authors have declared no conflict of interests related to the study.

© 2020 The Authors.

Figures

Fig. 1
Fig. 1
Flowchart of study enrollment. DS-MCCE, detachable string magnetically controlled capsule endoscopy; EGD, esophagogastroduodenoscopy.
Fig. 2
Fig. 2
Examination procedure and representative examples of detachable string magnetically controlled capsule endoscopy and esophagogastroduodenoscopy. I. A thin and hollow string was attached on the capsule to allow the observation of esophagus by controlling the string. II. The capsule was released from the string after inspecting esophagus. III. The capsule was controlled to observe the stomach by the guidance of magnet robot. DS-MCCE, detachable string magnetically controlled capsule endoscopy; EGD, esophagogastroduodenoscopy.
Fig. 3
Fig. 3
Diagnostic performance of detachable string magnetically controlled capsule endoscopy and other non-invasive tools. A, Receiver operating characteristic curves of detachable string magnetically controlled capsule endoscopy (DS-MCCE) and image-based indexes; AUC, area under receiver operating characteristic curve; LSPS, liver stiffness-spleen size-to-platelet ratio score. B, Receiver operating characteristic curves of DS-MCCE and serum-based indexes. FIB-4, fibrosis index based on four factors; APRI, aspartate aminotransferase to platelet count ratio index; AAR, aspartate aminotransferase to alanine aminotransferase ratio; GPR, gamma glutamyl trans-peptidase to platelet count ratio.
Fig. 4
Fig. 4
Comparison of patients’ satisfaction score of detachable string magnetically controlled capsule endoscopy and esophagogastroduodenoscopy. A, Boxplot of patients’ satisfaction score of DS-MCCE and EGD without sedation (n = 89). B, Boxplot of patients’ satisfaction score of DS-MCCE and EGD with sedation (n = 10). DS-MCCE, detachable string magnetically controlled capsule endoscopy; EGD, esophagogastroduodenoscopy. Satisfaction score was tested using a student's t-test on paired data.

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Source: PubMed

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