Clinical trial NCT04085211: Image-Enhanced Endoscopy in the Gastrointestinal Tract
Official title: A Series of Prospective Observational Studies Investigating the Clinical Utility of Image-enhanced Endoscopy in the Gastrointestinal (GI) Tract
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastro-Intestinal Disorder
Inflammatory Bowel Diseases
Gastro Esophageal Reflux
Atrophic Gastritis
Neuroendocrine Tumors
Keywords: endoscopy
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from a hospital setting, predominantly an outpatient setting where an endoscopic procedure is required part of routine care.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity, specificity, positive predictive value of specific endoscopic image enhancement findings to diagnose or stage the severity of different gastrointestinal conditions
timeFrame: 8 weeks
Secondary outcomes:
measure: Specific image enhancement findings to predict relapse for patients with inactive inflammatory bowel disease.
timeFrame: 12 months
measure: median duration for image enhanced endoscopy procedures
timeFrame: 1 day
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Department of Gastroenterology, King's College Hospital
Study officials:
affiliation: King's College Hospital NHS Trust
name: Bu'Hussain Hayee, PhD, MBBS,
role: PRINCIPAL_INVESTIGATOR
References: