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

Recruiting now

Conditions studied: Endoscopy

In brief

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.

Key facts

Study ID

NCT06467929

Run by

University Hospital, Ghent

People needed

510

Starts

2022-12-22

Expected to finish

2025-10-30

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University Hospital Ghent — Ghent, East Flanders, Belgium (enrolling)

Full record on ClinicalTrials.gov

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