Fintan John O'Hara, MBChB, Consultant Physician-Scientist, Department of Gastroenterology, Tallaght University Hospital, Tallaght, Dublin 24 D24 NR0A, Ireland. fintan.ohara@gmail.com
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Prospective Study
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (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: http://creativecommons.org/licenses/by-nc/4.0/
Fintan John O'Hara, Conor Costigan, Deirdre McNamara
Fintan John O'Hara, Conor Costigan, Department of Gastroenterology, Tallaght University Hospital, Dublin 24 D24 NR0A, Ireland
Deirdre McNamara, Trinity Academic Gastroenterology Group, School of Medicine - Trinity College Dublin, Dublin 24 D24 NR0A, Ireland
Author contributions: O'Hara FJ and McNamara D designed the research study; O'Hara FJ and Costigan C performed the research; O'Hara FJ analyzed the data and wrote the manuscript; all authors have read and approved the final manuscript.
Institutional review board statement: The study was reviewed and approved by the SJH/TUH Joint Research Ethics Committee Institutional Review Board (Approval No. 822).
Clinical trial registration statement: The study has been approved by the Ethics committee and does not require clinical registration.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors have not declared any conflicts of interest.
Data sharing statement: Technical appendix, statistical code, and anonymised dataset available from the corresponding author at fintan.ohara@tuh.ie.
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: Fintan John O'Hara, MBChB, Consultant Physician-Scientist, Department of Gastroenterology, Tallaght University Hospital, Tallaght, Dublin 24 D24 NR0A, Ireland. fintan.ohara@gmail.com
Received: June 9, 2024 Revised: August 27, 2024 Accepted: November 6, 2024 Published online: December 16, 2024 Processing time: 185 Days and 9.1 Hours
Abstract
BACKGROUND
Capsule endoscopy (CE) is a pivotal diagnostic tool for gastrointestinal (GI) disorders, yet capsule retention poses a significant risk, especially in patients with known risk factors. The patency capsule (PC) helps assess the functional patency of the GI tract to mitigate this risk. However, the standard 28-hour protocol for confirming patency often results in high false-positive rates, unnecessarily excluding many patients from undergoing diagnostic CE.
AIM
To investigate the use of a 72-hour extended patency protocol to improve functional patency rates in patients at risk of capsule retention.
METHODS
We performed a prospective, open-label study evaluating an extended 72-hour protocol for confirming functional patency with the PC. Conducted over six months, 135 patients with risk factors for capsule retention were enrolled. The primary endpoint was the capsule retention rate in patients with confirmed functional patency. Secondary endpoints included the rates of confirmed patency via self-reporting or radiology, small bowel transit times, and adverse events.
RESULTS
Functional patency was confirmed in 48.9% (n = 66) of patients within 28 hours, with an additional 17.4% (n = 12) confirmed within 72 hours, increasing the overall patency rate to 57.8%. There was no significant difference in small bowel transit time between patients confirmed for patency at 28 hours vs those confirmed at 72 hours. Importantly, no capsule retention was observed in patients who were confirmed for patency under the extended protocol. Notably, 50% (n = 39) of patients who proceeded to CE had clinically significant findings.
CONCLUSION
Extending the patency assessment protocol to 72 hours significantly improves the rate of confirmed functional patency without increasing the risk of capsule retention. This protocol is safe, effective, and cost-neutral, allowing more patients to benefit from CE. Further studies are recommended to refine the protocol and enhance its clinical utility.
Core Tip: Extending the patency capsule assessment window to 72 hours significantly increases the confirmed functional patency rate from 48.9% to 57.8% in high-risk patients undergoing capsule endoscopy (CE), without increasing the risk of capsule retention. This simple and cost-neutral modification can enhance patient care by reducing unnecessary exclusions from CE.
