Gastroesophageal Reflux Disease
Conditions
Keywords
Diagnostic technique and procedure
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.
Interventions
DEVICEEndoscopy (FICE and pCLE)
FICE is Flexible Spectral Imaging Color Enhancement and pCLE is probe-based Confocal Lase Endomicroscopy
Sponsors
King Chulalongkorn Memorial Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MERD diagnosis from FICE plus pCLE. | 8 months |
| Interobserver agreement in pCLE for MERD diagnosis | 8 months |
Countries
Thailand
Outcome results
None listed