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

NCT04349904 | Completed DMC

• 1 other identifier: 222807
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease

Outcome Measures

Primary Outcomes (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).

  Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, Accuracy

  6 weeks post endoscopy and duodenal biopsy

Secondary Outcomes (1)

• To develop and initially validate a novel NF-NBI classification of VA

  3 months post completion of data collection

Interventions

Near-Focus Narrow Band Imaging DIAGNOSTIC_TEST

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)

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Unable to give informed consent

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• Olympus: collaborator

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Related Publications (25)

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  PMID: 34228981 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

duodenal samples for histopathological evaluation

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Bu'Hussain Hayee, FRCP PhD

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 16, 2020
• Study Start: September 6, 2017
• Primary Completion: July 26, 2018
• Study Completion: February 3, 2019
• Last Updated: April 16, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)