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Near-Focus NBI Classification of Villous Atrophy in Suspected Coeliac Disease: International Development and Validation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04349904
Recruitment Status : Completed
First Posted : April 16, 2020
Last Update Posted : April 16, 2020
Sponsor:
Collaborator:
Olympus
Information provided by (Responsible Party):
King's College Hospital NHS Trust

Brief Summary:
There are no agreed endoscopic signs for the diagnosis of villous atrophy(VA) in coeliac disease(CD), necessitating biopsies and for both diagnosis and exclusion. Here we evaluated the role of near focus Narrow Band Imaging(NF-NBI) for the assessment of villous architecture in suspected CD with development and further validation of a novel NF-NBI classification.

Condition or disease Intervention/treatment
Celiac Disease Diagnostic Test: Near-Focus Narrow Band Imaging

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Near-Focus Narrow Band Imaging Classification of Villous Atrophy in Suspected Coeliac Disease: International Development and Validation
Actual Study Start Date : September 6, 2017
Actual Primary Completion Date : July 26, 2018
Actual Study Completion Date : February 3, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Near-Focus Narrow Band Imaging
    High Definition White Light Endoscopic Imaging followed by Near-Focus Narrow Band Imaging and target biopsy of 6 areas of the duodenum (2 from the first part and 4 from the second part of the duodenum)


Primary Outcome Measures :
  1. To evaluate the diagnostic performance of Near-Focus NBI (NF-NBI) for the diagnosis and assessment of Villous Atrophy (VA) in suspected Coeliac Disease (CD). [ Time Frame: 6 weeks post endoscopy and duodenal biopsy ]
    Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, Accuracy


Secondary Outcome Measures :
  1. To develop and initially validate a novel NF-NBI classification of VA [ Time Frame: 3 months post completion of data collection ]
    Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, Accuracy, Inter-observer agreement


Biospecimen Retention:   Samples Without DNA
duodenal samples for histopathological evaluation


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Probability Sample
Study Population
Consecutive patients attending the gastroenterology department requiring gastroscopy and duodenal biopsy to evaluate Villous Atrophy (VA) were approached for recruitment. All patients were recruited who satisfied British Society of Gastroenterology (BSG) criteria for the investigation of suspected Coeliac Disease (CD): positive coeliac serology, iron deficiency anaemia, weight loss, bloating, diarrhoea
Criteria

Inclusion Criteria:

  • Adult patients 18-90 years old
  • Retaining capacity and medically fit for gastroscopy
  • Requiring gastroscopy by current BSG guidelines for the investigation of anaemia or symptoms to suggest CD or positive serology.
  • Assessment of CD

Exclusion Criteria:

  • Outside inclusion age range
  • Unable to give informed consent
  • Clinical indication not satisfying 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): NCT04349904


Locations
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United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
King's College Hospital NHS Trust
Olympus
Investigators
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Principal Investigator: Bu'Hussain Hayee, FRCP PhD King's College Hospital NHS Trust
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT04349904    
Other Study ID Numbers: 222807
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Shared upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Celiac Disease
Atrophy
Pathological Conditions, Anatomical
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases