Image-Enhanced Endoscopy in the Gastrointestinal Tract

King's College Hospital NHS Trust

Status: Unknown

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

Study type: Observational

Funder types: Other

Identifiers

NCT04085211

KCH19-069

Details and patient eligibility

About

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

Full 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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

260 participants in 4 patient groups

Inflammatory Bowel Disease

Description:

Patients with an established diagnosis of ulcerative colitis or Crohn's Disease who require either a flexible sigmoidoscopy or colonoscopy as part of routine care (e.g. surveillance or staging disease activity)

Patients with symptoms of gastro-oesophageal reflux disease

Description:

Patients with symptoms of gastro-oesophageal reflux disease requiring a gastroscopy as part of routine clinical care.

Atrophic gastritis

Description:

Patients with known or suspected atrophic gastritis that require a gastroscopy to either confirm the diagnosis or surveillance for pre-cancerous changes.

Neuroendocrine Tumours

Description:

Patients with an established history of gastric neuroendocrine tumours requiring surveillance