An observational study in Gastro-Intestinal Disorder, Inflammatory Bowel Diseases and Gastro Esophageal Reflux, sponsored by King's College Hospital NHS Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-11-30.
Sponsored by King's College Hospital NHS Trust · Observational
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
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.
676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.
This study's planned enrollment of 260 is above the median of 115 across 176 observational studies indexed under Neuroendocrine Tumors.
Browse Neuroendocrine Tumors studies →King's College Hospital NHS Trust is the lead sponsor of 164 studies on the registry; 54 are open to participants now.
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Patients will be selected from a hospital setting, predominantly an outpatient setting where an endoscopic procedure is required part of routine care.
Exclusion Criteria:
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 requiring a gastroscopy as part of routine clinical care.
Patients with known or suspected atrophic gastritis that require a gastroscopy to either confirm the diagnosis or surveillance for pre-cancerous changes.
Patients with an established history of gastric neuroendocrine tumours requiring surveillance
Sensitivity, specificity, positive predictive value of specific endoscopic image enhancement findings to diagnose or stage the severity of different gastrointestinal conditions
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
Time frame: 8 weeks
Specific image enhancement findings to predict relapse for patients with inactive inflammatory bowel disease.
Relapse as defined by the requirement for treatment escalation, surgery, hospital admission; biochemical evidence of relapse (faecal calprotectin) or worsening inflammation on repeat endoscopy.
Time frame: 12 months
median duration for image enhanced endoscopy procedures
median duration (minutes) as defined as the time interval between insertion and completed withdrawal of the endoscope
Time frame: 1 day
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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King's College Hospital NHS Trust