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
ARTICLE HIGHLIGHTS
Research background

Esophagogastroduodenoscopy (EGD), the gold standard for diagnosing esophageal diseases, is invasive and can cause patient discomfort. Magnetically controlled capsule endoscopy (MCE) is a noninvasive alternative, yet its application for esophageal conditions is limited.

Research motivation

This study was motivated by the need to enhance patient compliance and comfort during esophageal examinations while maintaining high diagnostic accuracy.

Research objectives

The primary aim was to assess the safety and diagnostic efficacy of detachable string MCE (ds-MCE) for identifying esophageal diseases.

Research methods

A prospective, blinded, self-controlled clinical study was conducted to compare ds-MCE with EGD across various diagnostic parameters and patient tolerance levels in 50 subjects with known esophageal diseases.

Research results

Ds-MCE demonstrated diagnostic accuracy comparable to that of EGD (86%) and was preferred by patients, with 80% reporting a comfortable or very comfortable experience.

Research conclusions

Ds-MCE is an effective and patient-friendly diagnostic tool for esophageal diseases, offering a noninvasive alternative to traditional EGD with similar diagnostic outcomes.

Research perspectives

Further studies should expand patient demographics to validate the utility of ds-MCE across various populations and evaluate its cost-effectiveness for broader clinical adoption.