Clinical Trials Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Mar 7, 2024; 30(9): 1121-1131
Published online Mar 7, 2024. doi: 10.3748/wjg.v30.i9.1121
Detachable string magnetically controlled capsule endoscopy for the noninvasive diagnosis of esophageal diseases: A prospective, blind clinical study
Yan-Ling Yang, Huang-Wen Qin, Zhao-Yu Chen, Hui-Ning Fan, Yi Yu, Wei Da, Jin-Shui Zhu, Jing Zhang
Yan-Ling Yang, Huang-Wen Qin, Zhao-Yu Chen, Hui-Ning Fan, Yi Yu, Wei Da, Jin-Shui Zhu, Jing Zhang, Department of Gastroenterology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200233, China
Co-corresponding authors: Jin-Shui Zhu and Jing Zhang.
Author contributions: Zhang J, Zhu JS and Da W conceptualized and designed the research; Da W, Yang YL and Qin HW screened patients and acquired clinical data; Chen ZY and Fan HN collected the clinical data; Yu Y performed Data analysis; Yang YL wrote the paper. All the authors have read and approved the final manuscript. Both Zhang J and Zhu JS have played important and indispensable roles in the experimental design, data interpretation and manuscript preparation as the co-corresponding authors. Zhu JS applied for and obtained the funds for this research project. Zhu JS conceptualized, designed, and supervised the whole process of the project. Zhu JS searched the literature, revised the early version of the manuscript with the focus on the safety of detachable string magnetically controlled capsule endoscopy (ds-MCE) for identifying esophageal diseases. Zhang J was instrumental and responsible for data re-analysis and re-interpretation, figure plotting, comprehensive literature search, preparation and submission of the current version of the manuscript with a new focus on the efficacy of ds-MCE for the diagnosis of esophageal diseases. This collaboration between Zhang J and Zhu JS is crucial for the publication of this manuscript and other manuscripts still in preparation.
Supported by the Science and Technology Commission of Shanghai, No. 18DZ1930309.
Institutional review board statement: The study was reviewed and approved by the Shanghai Sixth People's Hospital Institutional Review Board, No. 2019-082-(1).
Clinical trial registration statement: This study was registered with ClinicalTrials.gov. The registration identification number is NCT05469152.
Informed consent statement: All subjects understood and agreed to the study protocol and voluntarily signed the informed consent form.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Jing Zhang, MD, Associate Chief Physician, Department of Gastroenterology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, No. 600 Yishan Road, Shanghai 200233, China. jing5522724@vip.163.com
Received: November 22, 2023
Peer-review started: November 22, 2023
First decision: December 7, 2023
Revised: January 14, 2024
Accepted: February 1, 2024
Article in press: February 1, 2024
Published online: March 7, 2024
Processing time: 104 Days and 13.2 Hours
Abstract
BACKGROUND

Traditional esophagogastroduodenoscopy (EGD), an invasive examination method, can cause discomfort and pain in patients. In contrast, magnetically controlled capsule endoscopy (MCE), a noninvasive method, is being applied for the detection of stomach and small intestinal diseases, but its application in treating esophageal diseases is not widespread.

AIM

To evaluate the safety and efficacy of detachable string MCE (ds-MCE) for the diagnosis of esophageal diseases.

METHODS

Fifty patients who had been diagnosed with esophageal diseases were prospectively recruited for this clinical study and underwent ds-MCE and conventional EGD. The primary endpoints included the sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of ds-MCE for patients with esophageal diseases. The secondary endpoints consisted of visualizing the esophageal and dentate lines, as well as the subjects' tolerance of the procedure.

RESULTS

Using EGD as the gold standard, the sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of ds-MCE for esophageal disease detection were 85.71%, 86.21%, 81.82%, 89.29%, and 86%, respectively. ds-MCE was more comfortable and convenient than EGD was, with 80% of patients feeling that ds-MCE examination was very comfortable or comfortable and 50% of patients believing that detachable string v examination was very convenient.

CONCLUSION

This study revealed that ds-MCE has the same diagnostic effects as traditional EGD for esophageal diseases and is more comfortable and convenient than EGD, providing a novel noninvasive method for treating esophageal diseases.

Keywords: Clinical trial; Detachable string magnetically controlled capsule endoscopy; Esophagogastroduodenoscopy; Noninvasive diagnosis; Esophageal diseases

Core Tip: Our study highlights detachable string magnetically controlled capsule endoscopy (ds-MCE) as an innovative, noninvasive technique for esophageal diagnosis that matches the 86% accuracy of traditional esophagogastroduodenoscopy while significantly enhancing patient comfort. With 80% of patients reporting a favorable experience, ds-MCE stands to increase compliance and revolutionize the approach to esophageal disease management, offering a promising leap forward in gastroenterological diagnostics with minimal patient discomfort.