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Image-Enhanced Endoscopy in the Gastrointestinal Tract

A Series of Prospective Observational Studies Investigating the Clinical Utility of Image-enhanced Endoscopy in the Gastrointestinal (GI) Tract

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04085211
Enrollment
260
Registered
2019-09-11
Start date
2019-07-01
Completion date
2022-05-31
Last updated
2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrophic Gastritis, Gastro Esophageal Reflux, Gastro-Intestinal Disorder, Inflammatory Bowel Diseases, Neuroendocrine Tumors

Keywords

endoscopy

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.

Interventions

None listed

Sponsors

King's College Hospital NHS Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity, specificity, positive predictive value of specific endoscopic image enhancement findings to diagnose or stage the severity of different gastrointestinal conditions8 weeksIdentify 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

MeasureTime frameDescription
Specific image enhancement findings to predict relapse for patients with inactive inflammatory bowel disease.12 monthsRelapse 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 procedures1 daymedian duration (minutes) as defined as the time interval between insertion and completed withdrawal of the endoscope

Countries

United Kingdom

Contacts

Primary ContactMehul Patel, MBBS, BSc
mehul.patel4@nhs.net02032996044
Backup ContactLee Meng Choong
kch-tr.IBDtrials@nhs.net02032991591

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026