Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
260 participants
OBSERVATIONAL
2019-07-01
2022-05-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Inflammatory Bowel Disease
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)
No interventions assigned to this group
Patients with symptoms of gastro-oesophageal reflux disease
Patients with symptoms of gastro-oesophageal reflux disease requiring a gastroscopy as part of routine clinical care.
No interventions assigned to this group
Atrophic gastritis
Patients with known or suspected atrophic gastritis that require a gastroscopy to either confirm the diagnosis or surveillance for pre-cancerous changes.
No interventions assigned to this group
Neuroendocrine Tumours
Patients with an established history of gastric neuroendocrine tumours requiring surveillance
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patient has mental capacity to consent
* Requires endoscopic procedure as part of routine care
18 Years
90 Years
ALL
No
Sponsors
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King's College Hospital NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Bu'Hussain Hayee, PhD, MBBS,
Role: PRINCIPAL_INVESTIGATOR
King's College Hospital NHS Trust
Locations
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Department of Gastroenterology, King's College Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Mehul Patel, MBBS
Role: primary
Other Identifiers
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KCH19-069
Identifier Type: -
Identifier Source: org_study_id