Image-Enhanced Endoscopy in the Gastrointestinal Tract

• Conditions: Gastro-Intestinal Disorder; Gastro Esophageal Reflux; Atrophic Gastritis; Neuroendocrine Tumors; Inflammatory Bowel Diseases

• Registration Number: NCT04085211
• Lead Sponsor: King's College Hospital NHS Trust

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-11
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-27
• Last Update Posted: 2020-11-30
• Primary Completion: 2022-02
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• Age > 18 years old
• Patient has mental capacity to consent
• Requires endoscopic procedure as part of routine care

Exclusion Criteria

• not meeting inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity, specificity, positive predictive value of specific endoscopic image enhancement findings to diagnose or stage the severity of different gastrointestinal conditions	8 weeks	Identify specific features on NBI,BLI, LCI, magnification and endocytoscopy to accurately diagnose / grade severity of a range of conditions when compared to the gold standard diagnostic investigation e.g. biopsy, pH impedance testing

Secondary Outcome Measures

Name	Time	Method
Specific image enhancement findings to predict relapse for patients with inactive inflammatory bowel disease.	12 months	Relapse as defined by the requirement for treatment escalation, surgery, hospital admission; biochemical evidence of relapse (faecal calprotectin) or worsening inflammation on repeat endoscopy.
median duration for image enhanced endoscopy procedures	1 day	median duration (minutes) as defined as the time interval between insertion and completed withdrawal of the endoscope

Trial Locations

Locations (1)

Department of Gastroenterology, King's College Hospital; 🇬🇧 London, United Kingdom