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Image-Enhanced Endoscopy in the Gastrointestinal Tract

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ClinicalTrials.gov Identifier: NCT04085211
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Bu' Hussain Hayee, King's College Hospital NHS Trust

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


Condition or disease
Gastro-Intestinal Disorder Inflammatory Bowel Diseases Gastro Esophageal Reflux Atrophic Gastritis Neuroendocrine Tumors

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.


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Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Series of Prospective Observational Studies Investigating the Clinical Utility of Image-enhanced Endoscopy in the Gastrointestinal (GI) Tract
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Group/Cohort
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)
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.
Atrophic gastritis
Patients with known or suspected atrophic gastritis that require a gastroscopy to either confirm the diagnosis or surveillance for pre-cancerous changes.
Neuroendocrine Tumours
Patients with an established history of gastric neuroendocrine tumours requiring surveillance



Primary Outcome Measures :
  1. Sensitivity, specificity, positive predictive value of specific endoscopic image enhancement findings to diagnose or stage the severity of different gastrointestinal conditions [ Time Frame: 8 weeks ]
    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


Secondary Outcome Measures :
  1. Specific image enhancement findings to predict relapse for patients with inactive inflammatory bowel disease. [ Time Frame: 12 months ]
    Relapse as defined by the requirement for treatment escalation, surgery, hospital admission; biochemical evidence of relapse (faecal calprotectin) or worsening inflammation on repeat endoscopy.

  2. median duration for image enhanced endoscopy procedures [ Time Frame: 1 day ]
    median duration (minutes) as defined as the time interval between insertion and completed withdrawal of the endoscope



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085211


Contacts
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Contact: Mehul Patel, MBBS, BSc 02032996044 mehul.patel4@nhs.net
Contact: Lee Meng Choong 02032991591 kch-tr.IBDtrials@nhs.net

Locations
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United Kingdom
Department of Gastroenterology, King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Contact: Mehul Patel, MBBS    02032996044      
Sponsors and Collaborators
King's College Hospital NHS Trust
Investigators
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Principal Investigator: Bu'Hussain Hayee, PhD, MBBS, King's College Hospital NHS Trust

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Responsible Party: Dr Bu' Hussain Hayee, Reader in Gastroenterology / Clinical Lead for Gastroenterology, King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT04085211     History of Changes
Other Study ID Numbers: KCH19-069
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Bu' Hussain Hayee, King's College Hospital NHS Trust:
endoscopy
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Intestinal Diseases
Inflammatory Bowel Diseases
Gastritis
Gastroesophageal Reflux
Gastritis, Atrophic
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Stomach Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases