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

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Device: Endoscopy (FICE and pCLE)

• Registration Number: NCT02336100
• Lead Sponsor: King Chulalongkorn Memorial Hospital

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.

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2012-02
• Study Completion: 2012-06
• Study First Submitted: 2015-01-06
• Study First Submitted QC: 2015-01-07
• Study First Posted: 2015-01-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GERD patient	Endoscopy (FICE and pCLE)	36 GERD patients without obviously abnormality were examined by FICE and then followed by pCLE to evaluate minimal change esophagitis
Control	Endoscopy (FICE and pCLE)	18 control patients were were examined by FICE and then followed by pCLE to evaluate minimal change esophagitis

Primary Outcome Measures

Name	Time	Method
MERD diagnosis from FICE plus pCLE.	8 months
Interobserver agreement in pCLE for MERD diagnosis	8 months

Trial Locations

Locations (1)

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Patum Wan, Thailand