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

Gastroesophageal Reflux Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02336100
• Other study ID #: RP010
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: February 2019
• Source: King Chulalongkorn Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Device:
• Endoscopy (FICE and pCLE)
FICE is Flexible Spectral Imaging Color Enhancement and pCLE is probe-based Confocal Lase Endomicroscopy

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Bangkok	Patum Wan

Sponsors (1)

Lead Sponsor	Collaborator
King Chulalongkorn Memorial Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MERD diagnosis from FICE plus pCLE.		8 months
Primary	Interobserver agreement in pCLE for MERD diagnosis		8 months