Virtual Chromoendoscopy With Magnification in Coeliac Disease.

March 30, 2022 updated by: Instituto Ecuatoriano de Enfermedades Digestivas

Optical Enhancement Virtual Chromoendoscopy With High-definition Optical Magnification for Duodenal Mucosa Characterization in Coeliac Disease Patients.

High-definition white light endoscopy (HD-WLE) does not usually allow the visualization of duodenal villous patterns and may be inaccurate for assessing coeliac disease (CD). To the best of the knowledge of the authorship, there is no prospective study that has evaluated the accuracy of combining high-definition optical magnification (HD-OM) with i-Scan optical enhancement (OE) virtual chromoendoscopy for evaluation of duodenal villous patterns in the context of CD suspicion. Combining both techniques can also guide better duodenal biopsies. This study pursues to compare diagnostic accuracy between HD-WLE and HD-OM with OE using histology as the gold standard in detecting villous abnormalities in CD.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

High-definition white light endoscopy (HD-WLE) does not usually allow the visualization of duodenal villous patterns and may be inaccurate for assessing coeliac disease (CD). In addition, HD-WLE findings depend on CD severity. The lesser the disease severity, the higher possibility of showing a normal HD-WLE appearance. Thus, sampling routine duodenal biopsies have been suggested. However, this is time-consuming, expensive, and maybe excessive in low-risk groups. Sampling routine duodenal biopsies could also be unsuccessful, obtaining normal biopsies.

Novel endoscopic techniques have played an exciting role in increasing the accuracy of macroscopic evaluation of duodenal villous patterns. There have been described retrospective and prospective studies using chromoendoscopy, narrow-band imaging, optical coherence tomography, water immersion, confocal laser endomicroscopy, high-resolution magnification endoscopy, capsule endoscopy, and I-scan technology. However, results are disjunct, with no consensus.

The iSCAN optical enhancementTM (OE) System (PENTAX Medical, Tokyo, Japan) virtual chromoendoscopy has been developed to improve the blood vessels' visibility, ducts of the glands, and surface structures in addition to the traditional iSCAN functions. High-definition optical magnification (HD-OM) endoscopes have been developed and can combine HD imaging with OM to produce detailed images with a magnification of up to 136X. This imaging technique facilitates the evaluation of the superficial vascular aspects of the mucosa, enabling the identification of early signs of inflammation or lesions not previously seen with conventional endoscopy.

Prospective data have demonstrated that magnification endoscopy has superior diagnostic sensitivity in detecting villous atrophy compared to HD-WLE, being efficiently handled by all endoscopists. On another side, virtual chromoendoscopy has shown disjunct results across the literature. To the best of the knowledge of the authorship, there is no prospective study that has assessed the accuracy of combining HD-OM with i-Scan OE for evaluation of duodenal villous patterns in the context of CD suspicion. Combining both techniques can also guide better duodenal biopsies.

This study pursues to better characterize duodenal mucosa through OE with HD-OM in gluten-free diet (GFD) naïve patients with CD suspicion to correlate these findings with histology. As a second aim, to compare diagnostic accuracy between HD-WLE and HD-OM with OE using histology as the gold standard in detecting villous abnormalities in CD.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ecuador
    • Guayas
      • Guayaquil, Guayas, Ecuador, 090505
        • Ecuadorian Institute of Digestive Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients, naïve to GFD, with clinical suspicion of CD who underwent endoscopic assessment.

Description

Inclusion Criteria:

  • Patients naïve to GFD;
  • With clinical history suggestive of malabsorption (weight loss, chronic diarrhea, iron-deficiency, anemia, etc.);
  • And serologic suspicion of CD as positive or borderline antiendomysial (normal values are absent for both IgA and IgG) and antitransglutaminase antibodies (normal values 0-10 U/mL).

Exclusion Criteria:

  • Presence of severe gastrointestinal or systemic disease (e.g., chronic pancreatitis, liver cirrhosis, and blood coagulation disorders) impacts cardiovascular risk assessment.
  • Presence of duodenal ulcer in the context of patients with upper gastrointestinal bleeding.
  • History of any type of duodenal surgery.
  • Pregnancy or nursing female.
  • Refusal to participate in this observational trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marsh's classification as revised by Oberhuber et al.
Time Frame: Six months
Histology findings will be recorded and graded according to Marsh's classification as revised by Oberhuber et al (Marsh 0, Marsh 1, Marsh 2, Marsh 3a, Marsh 3b, and Marsh 3c). HD-WLE and HD-OM findings will be correlated with Marsh's classification. Finally, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of HD-WLE and HD-OM will be calculated, considering Marsh's classification as gold standard.
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Ecuatoriano de Enfermedades Digestivas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

October 15, 2021

First Submitted That Met QC Criteria

October 28, 2021

First Posted (Actual)

November 2, 2021

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 30, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IECED-10142021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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