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Virtual Chromoendoscopy With Magnification in Coeliac Disease.

NCT05103150 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2022-03-31

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

High-definition white light endoscopy (HD-WLE)

Evaluation of the duodenal mucosa with HD-WLE (EG-29i10 gastroscope and EPKi7010 video processor). The endoscopy images will be seen on a 27inch, flat panel, high-definition LCD monitor (Radiance™ ultraSC-WU27-G1520 model) by one endoscopist, randomly assigned via esophagogastroduodenoscopy. There were used the following standard endoscopic findings were: a) "scalloping" or dented aspect of the duodenal folds; b) submucosal vascular pattern; c) "mosaicism" or micronodular look of the mucosa; d) grooves and fissurations of the mucosa.

DIAGNOSTIC_TEST

HD-WLE plus I-Scan optical enhancement (OE) virtual chromoendoscopy with High-definition optical magnification (HD-OM)

Evaluation of the duodenal mucosa through upper endoscopy with the OE System (EPK-i7010 HD Video Processor and MagniView™ EG-2990Zi Video Gastroscope) with intravenous sedation in a standardized manner. This technique involves using a distal black rubber hood (OE-A58; Pentax) at the tip of the endoscope, to fix the distance between the tip of the endoscope and the gastric mucosa at 2 mm. The OE System will be used in mode one and mode two without HD-OM to obtain an overview of the duodenal surface and identify any changes in the mucosa, then HD-OM will be implemented. There were used OE criteria as previously validated by Cammarota et al: brightness, Ave/peak, blue, red, surface, contrast, and tone enhancement.

Sponsors & Collaborators

  • Instituto Ecuatoriano de Enfermedades Digestivas

    lead OTHER

Principal Investigators

  • Carlos Robles-Medranda, MD FASGE · Ecuadorian Institute of Digestive Diseases

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-12-01
Completion
2023-01-01

Countries

  • Ecuador

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05103150 on ClinicalTrials.gov