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Grading Atrophic Gastritis by Confocal Laser Endomicroscopy Probe (p-CLE)

NCT02351154 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-01-30

No results posted yet for this study

Summary

Atrophic gastritis (AG) is a chronic disease, associated to gastric adenocarcinoma moreover if severity AG is present. Sydney system classified AG as mild, moderate and severe, but with moderate interobserver agreement, due to this system is based in a visual analogic scale (qualitative analysis). Confocal endomicroscopy showed an accuracy of 98% for diagnosis gastric diseases, but when grading AG still remains a qualitative measure. Recently, a new software called "Cellvizio® Viewer" (CV) permits to measure in micrometers (µm) the structures observed after confocal laser endomicroscopy probe studies. Based on the hypothesis that AG severity is correlated with crypts size diminution, the aim of this study is to determine a quantitative way to classify the severity of AG measuring the crypt area and inter-crypt spaces in patients with AG.

Conditions

  • Atrophic Gastritis

Interventions

OTHER

Cellvizio Viewer software

permets to perform analysis of diameters in micrometers

Sponsors & Collaborators

  • Instituto Ecuatoriano de Enfermedades Digestivas

    lead OTHER

Principal Investigators

  • Carlos Robles-Medranda, MD · Instituto Ecuatoriano de Enfermedades Digestivas

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-10-31
Completion
2014-11-30

Countries

  • Ecuador

Study Locations

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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 NCT02351154 on ClinicalTrials.gov