Image-Enhanced Endoscopy in the Gastrointestinal Tract

Inflammatory Bowel Diseases Clinical Trial

Official title: A Series of Prospective Observational Studies Investigating the Clinical Utility of Image-enhanced Endoscopy in the Gastrointestinal (GI) Tract

Status Recruiting

Clinical Trial Summary

This study evaluates a range of endoscopic image enhancement techniques for assessing conditions involving the gastrointestinal tract.

This study aims to determine:

(i) the accuracy of different techniques to diagnose or grade severity of several gastrointestinal conditions

(ii) if image-enhancement techniques could potentially replace investigations currently used in daily practice (e.g. biopsy) with a view to reduce costs and shorten the interval to initiate treatment

Clinical Trial Description

Endoscopic procedures are performed on a daily basis to visualise the gastrointestinal tract for diagnosis and intervention. The demand for procedures is growing, consequently increasing the number of additional investigations; for example, biopsies. Image enhancement techniques can be performed during procedures either digitally or through the use of dye. These techniques alter the qualities of the image e.g. colour, contrast and magnification. We believe these techniques have several potential benefits: (i) improve diagnostic accuracy (ii) filter appropriate selection of additional investigations to maximise diagnostic yield (iii) the potential to replace existing investigations which are costly and intricate.

Participants included in the study will have an endoscopic procedure as indicated for routine clinical care. On the day of the procedure (or before), a baseline assessment will be performed - symptom questionnaires, medical history and recording any relevant investigation results performed as part of routine care. Participants will have the endoscopic procedure as normal, with additional images and video obtained using different image enhancement techniques. Select patients will have follow-up for up to one year to determine relapse. The image enhancement technique findings will be compared to the gold standard investigation currently available as part of routine care for the condition of interest.

The study will look at a range of different image enhancement techniques: dye chromoendoscopy, blue laser imaging (BLI), linked colour imaging (LCI), narrow band imaging (NBI), image magnification and endocytoscopy. This will involve a range of gastrointestinal conditions.

Ethics Approval: favourable opinion was provided by the East Midlands - Derby research and ethics committee, reference: 19/EM/0167. ;

Related Conditions & MeSH terms

• Atrophic Gastritis
• Digestive System Diseases
• Gastritis
• Gastritis, Atrophic
• Gastro Esophageal Reflux
• Gastro-Intestinal Disorder
• Gastroesophageal Reflux
• Gastrointestinal Diseases
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Neuroendocrine Tumors

• NCT number: NCT04085211
• Study type: Observational
• Source: King's College Hospital NHS Trust
• Contact: Mehul Patel, MBBS, BSc
• Phone: 02032996044
• Email: mehul.patel4@nhs.net
• Status: Recruiting
• Start date: July 1, 2019
• Completion date: May 2022