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

Primary Purpose

Gastroesophageal Reflux Disease

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Endoscopy (FICE and pCLE)

About this trial

This is an interventional diagnostic trial for Gastroesophageal Reflux Disease focused on measuring Diagnostic technique and procedure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

King Chulalongkorn Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

GERD patient

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

MERD diagnosis from FICE plus pCLE.

Interobserver agreement in pCLE for MERD diagnosis

Secondary Outcome Measures

Full Information

NCT ID

NCT02336100

First Posted

January 6, 2015

Last Updated

February 26, 2019

Sponsor

King Chulalongkorn Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02336100

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

King Chulalongkorn Memorial Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux Disease

Keywords

Diagnostic technique and procedure

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GERD patient

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Endoscopy (FICE and pCLE)

Intervention Description

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

Primary Outcome Measure Information:

Title

MERD diagnosis from FICE plus pCLE.

Time Frame

8 months

Title

Interobserver agreement in pCLE for MERD diagnosis

Time Frame

8 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rapat Pittayanon, MD

Organizational Affiliation

king

Official's Role

Principal Investigator

Facility Information:

Facility Name

King Chulalongkorn Memorial Hospital

City

Bangkok

State/Province

Patum Wan

ZIP/Postal Code

10330

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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