Diagnostic Value of Flexible Spectral Imaging Color Enhancement (FICE) Plus Probe-based Confocal Laser Endomicroscopy (pCLE) for Minimal Change Esophageal Reflux Disease (MERD) Diagnosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-06-30

Brief Summary

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Gastroesophageal reflux disease (GERD) patients without obvious mucosal break by endoscopy were examined by FICE, followed by confocal. Validity scores for MERD diagnosis were analyzed.

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Detailed Description

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Thirty-six patients with suspected MERD (positive GerdQ but normal conventional endoscopy) and eighteen asymptomatic control were recruited. The new FICE (EPX-4450HD) was performed at non-magnified, x50, and x100 zoom levels. The criteria for positive FICE were; A) triangular indentation, B) punctuate erythema, C) villiform mucosa, or D) increased number of capillary vessel. At the same session, pCLE was applied to count the number of intrapapillary capillary loops (IPCLs) by using more than 5 IPCLs in 500x500 micron area as a criterion for MERD diagnosis. The validity scores of both modalities and interobserever agreement of pCLE interpretation was assessed.

Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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GERD patient

36 GERD patients without obviously abnormality were examined by FICE and then followed by pCLE to evaluate minimal change esophagitis

Group Type EXPERIMENTAL

Endoscopy (FICE and pCLE)

Intervention Type DEVICE

FICE is Flexible Spectral Imaging Color Enhancement and pCLE is probe-based Confocal Lase Endomicroscopy

Control

18 control patients were were examined by FICE and then followed by pCLE to evaluate minimal change esophagitis

Group Type EXPERIMENTAL

Endoscopy (FICE and pCLE)

Intervention Type DEVICE

FICE is Flexible Spectral Imaging Color Enhancement and pCLE is probe-based Confocal Lase Endomicroscopy

Interventions

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Endoscopy (FICE and pCLE)

FICE is Flexible Spectral Imaging Color Enhancement and pCLE is probe-based Confocal Lase Endomicroscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. age more than 18 year old
2. no PPI therapy in previous 2 weeks and
3. no esophageal tumor or stenosis or history of esophageal surgery.

Exclusion Criteria

1. bleeding tendency including decompensated cirrhosis, chronic kidney disease
2. long term antiplatelets or anticoagulants,
3. pregnancy or
4. history of fluorescein allergy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes