Observational Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. May 28, 2022; 28(20): 2227-2242
Published online May 28, 2022. doi: 10.3748/wjg.v28.i20.2227
First prospective European study for the feasibility and safety of magnetically controlled capsule endoscopy in gastric mucosal abnormalities
Milán Szalai, Krisztina Helle, Barbara Dorottya Lovász, Ádám Finta, András Rosztóczy, László Oczella, László Madácsy
Milán Szalai, Ádám Finta, László Oczella, László Madácsy, Department of Gastroenterology, Endo-Kapszula Health Centre and Endoscopy Unit, Székesfehérvár 8000, Hungary
Krisztina Helle, András Rosztóczy, Department of Internal Medicine, University of Szeged, Szeged 6725, Hungary
Author contributions: Szalai M, Madácsy L and Finta Á performed the capsule endoscopy examinations; Szalai M, Helle K, Finta Á, Oczella L and Madácsy L performed the data collection; Szalai M, Helle K, Lovász BD, Finta Á, Rosztóczy A, Oczella L and Madácsy L drafted the manuscript; Oczella L enrolled participants; Szalai M and Madácsy L reviewed capsule endoscopy images as expert endoscopists with high experience in capsule endoscope; Rosztóczy A and Madácsy L planned the study concept, consulted with the authors, performed manuscript database validation, supervised the manuscript preparation and writing, and acted as the submission's guarantor; All authors finally read and approved the manuscript.
Institutional review board statement: This study was approved by the Ethical Committee of the University of Szeged (registry No. 5/17.04.26) and registered in the trial registry: ClinicalTrials.gov (Identifier: NCT03234725). The present study was conducted according to the World Medical Association's Declaration of Helsinki provisions in 1995.
Informed consent statement: All involved participants gave their informed consent (in written form) prior to study inclusion. Patients agreed to participate in the present study, undergo capsule endoscopy and Helicobacter pylori breaths tests by written informed consent. All details that might disclose the identity of the subjects under study are anonymized. The institutional review board of University of Szeged waived the requirement to obtain informed consents from patients.
Conflict-of-interest statement: No conflict-of-interest.
Data sharing statement: Data (deidentified participant data) are available upon reasonable request. Contact details: endomabt1@gmail.com; László Madácsy (0000-0002-7589-6193). No additional information or data is available.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
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: László Madácsy, MD, PhD, Professor, Department of Gastroenterology, Endo-Kapszula Health Centre and Endoscopy Unit, No. 316 Budai Road, Székesfehérvár 8000, Hungary. endomabt1@gmail.com
Received: January 3, 2022
Peer-review started: January 3, 2022
First decision: January 27, 2022
Revised: February 14, 2022
Accepted: April 27, 2022
Article in press: April 27, 2022
Published online: May 28, 2022
Processing time: 143 Days and 18.7 Hours
Research background

While capsule endoscopy (CE) is the gold standard diagnostic method of detecting small bowel diseases and disorders, a novel magnetically controlled capsule endoscopy (MCCE) system provides non-invasive evaluation of the gastric mucosal surface, which can be performed without sedation or discomfort.

Research motivation

During standard small bowel capsule endoscopy (SBCE), passive movement of the CE may cause areas of the complex anatomy of the gastric mucosa to remain unexplored, whereas the precision of MCCE capsule movements inside the stomach promises better visualization of the entire mucosa.

Research objectives

To evaluate the Ankon MCCE system’s feasibility, safety and diagnostic yield in patients with gastric or small bowel disorders.

Research methods

Of outpatients who were referred for SBCE, 284 (male/female: 149/135) were prospectively enrolled and evaluated by MCCE. The stomach was examined in the supine, left, and right lateral decubitus positions without sedation. Next, all patients underwent a complete small bowel CE study protocol. The gastric mucosa was explored with the Ankon MCCE system with active magnetic control of the capsule endoscope in the stomach, applying three standardized pre-programmed computerized algorithms in combination with manual control of the magnetic movements.

Research results

The urea breath test revealed Helicobacter pylori positivity in 32.7% of patients. The mean gastric and small bowel transit times with MCCE were 47 min 40 s and 3 h 46 min 22 s, respectively. The average total time of upper GI MCCE examination was 5 h 48 min 35 s min. Active magnetic movement of the Ankon capsule through the pylorus was successful in 41.9% of patients. Overall diagnostic yield for detecting abnormalities in the stomach and small bowel was 81.9% (68.6% minor; 13.3% major pathologies); 25.8% of abnormalities were in the small bowel; 74.2% were in the stomach. The diagnostic yield for stomach/small bowel was 55.9%/12.7% for minor and 4.9%/8.4% for major pathologies.

Research conclusions

MCCE is a feasible, safe diagnostic method for evaluating gastric mucosal lesions and is a promising non-invasive screening tool to decrease morbidity and mortality in upper gastrointestinal diseases.

Research perspectives

MCCE is promising as a non-invasive screening tool that may be applied in future monitoring of patients for evaluating gastric mucosal lesions and decreasing morbidity and mortality of benign and malignant upper GI disorders.