Prospective Collection of Endoscopic and Histopathologic Data from Endoscopic Procedures Performed in UZ Gent

NCT06467929 | Recruiting

• 1 other identifier: ONZ-2022-0177
• Study Type: observational
• Target: 510
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study in which images (photos and/or videos of lesions found during endoscopy) will be collected and the associated data about these lesions (size, location in the body, outcome of histology, if resected and examined). The images will be taken while performing a diagnostic or therapeutic endoscopy. This footage can be recorded in different light modalities, and various lesions can be removed during one procedure. It is of importance that the images are recorded in the best possible image quality. The images can be either endoscopic images or endoscopic images combined with room view (this means that the endoscopic room can be filmed, for example, to visualize the endoscopist and thus show techniques of the procedure, without the patient being identified). The GDPR regulations will be respected at all times during the video recordings. The purpose of this registry is to create a database with images in the form of photos and video clips, histopathological data, demographic data of patients and data about the endoscopic procedure. The recording of this data is standard with every endoscopic procedure that patients undergo at UZ Gent. The data will be used for the following purposes: linking procedural outcomes with procedural data and patient data to improve endoscopic technique and to guarantee quality in our endoscopic unit. In this way the investigators will also be able to identify trends and link adverse events back to the patient data with the aim of informing the patient. In addition, as a university center, the investigators can train doctors in training with this educational material. The footage can be shared via online and/or live presentations that are only accessible to/by healthcare workers and without the patient being identifiable. Such material and its dissemination is essential to improve (the safety of) techniques (such as those of today), to share knowledge about techniques, and in this way to train the next generation of doctors and nurses.

Conditions

Endoscopy

Keywords

endoscopy; histopathology; database

Outcome Measures

Primary Outcomes (1)

• Digital Database of Prospectively collected images, videos and data of endoscopic procedures

  Creation of a large digital database of prospectively collected images, videos and data of endoscopic procedures using any type of imaging technique (e.g., white light endoscopy, video chromoendoscopy, …) and with consecutive resection of lesions providing a corresponding histology report.

  01/11/2022 - 30/10/2025

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred for a surveillance, diagnostic or therapeutic endoscopy

You may qualify if:

• Age =\> 18 years
• Referral for a surveillance, diagnostic or therapeutic endoscopy
• Digital video material of the endoscopic procedure
• Digital images of the endoscopic procedure
• Videos and/or images can be made in white light or any virtual of dye-based enhancement technique
• Endoscopic procedures performed after IRB approval for this study
• Material collected in adult patients of all sex or race, including pregnant women

You may not qualify if:

• Age \< 18 years
• Any contraindication to undergo an endoscopic procedure
• Patient did not sign informed consent

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, East Flanders, 9000, Belgium

RECRUITING

Study Officials

• David Tate, Doctor

  UZ Gent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karolien Haenebalcke

CONTACT

93321063; karolien.haenebalcke@uzgent.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 21, 2024
• Study Start: December 22, 2022
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

BE (1)