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Magnified Intelligence Chromoendoscopy Plus Probe-based Confocal Laser Endomicroscopy for Gastric Intestinal Metaplasia Diagnosis

NCT01489397 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2014-06-11

No results posted yet for this study

Summary

Magnified intelligence chromoendoscopy (FICE) plus probe-based confocal laser endomicroscopy (pCLE) for Gastric Intestinal Metaplasia (GIM) diagnosis: a feasibility trial

Research Question:

Is confocal endomicroscope feasible to diagnose gastric intestinal metaplasia?

Objective:

To evaluate the feasibility of confocal endomicroscope in diagnose gastric intestinal metaplasia.

Hypothesis:

Confocal endomicreosocpe can provide the accurate diagnosis of gastric intestinal metaplasia.

Research design:

Diagnostic study

Sample size:

The investigators follow the population in recent study from Imraporn et al.: Validity of magnify NBI for gastric intestinal metaplasia targeted biopsy (N= 50)

Data analysis:

Confocal Barrett's esophagus classification was used to evaluate agreement of confocal endomicroscopic finding in gastric intestinal metaplasia. The accuracy of new criteria for GIM by confocal endomicroscope was evaluated in relation to pathological report, a gold standard for diagnosis, and reported as sensitivity, specificity, positive predictive value, negative predictive value and accuracy of these criteria.

Expected Benefit and Application:

The feasibility of confocal endomicroscopy for diagnosis gastric intestinal metaplasia in order to improve the quality of GIM/dysplasia/early gastric cancer detection and then decrease the mortality rate from gastric cancer in the future.

Conditions

  • Gastric Intestinal Metaplasia

Interventions

DEVICE

Confocol laser endomicroscopy

Confocal laser endomicroscopy was applied at suspected lesion and normal mucosa followed by biopsy for pathology.

Sponsors & Collaborators

  • King Chulalongkorn Memorial Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-12-31
Completion
2012-02-29

Countries

  • Thailand

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 NCT01489397 on ClinicalTrials.gov