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 Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Device: Endoscopy (FICE and pCLE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age more than 18 year old no PPI therapy in previous 2 weeks and no esophageal tumor or stenosis or history of esophageal surgery. Exclusion Criteria: bleeding tendency including decompensated cirrhosis, chronic kidney disease long term antiplatelets or anticoagulants, pregnancy or history of fluorescein allergy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GERD patient<br>36 GERD patients without obviously abnormality were examined by FICE and then followed by pCLE to evaluate minimal change esophagitis | Device: Endoscopy (FICE and pCLE)<br>* FICE is Flexible Spectral Imaging Color Enhancement and pCLE is probe-based Confocal Lase Endomicroscopy<br>|
| Experimental: Control<br>18 control patients were were examined by FICE and then followed by pCLE to evaluate minimal change esophagitis | Device: Endoscopy (FICE and pCLE)<br>* FICE is Flexible Spectral Imaging Color Enhancement and pCLE is probe-based Confocal Lase Endomicroscopy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MERD diagnosis from FICE plus pCLE. |  | 8 months | 
| Interobserver agreement in pCLE for MERD diagnosis |  | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnostic technique and procedure