A Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies

Phase 4

Terminated

• Conditions: Barrett's Esophagus
• Interventions: Other: Fluorescence-aided confocal endomicroscopy guided biopsy.; Other: Random four-quadrant biopsies.

• Registration Number: NCT01030263
• Lead Sponsor: Mayo Clinic

Brief Summary

We wish to determine whether biopsies obtained with the technique of fluorescence-aided confocal endomicroscopy will detect more patients with specialized columnar epithelium than random biopsies among patients with Barrett's esophagus who are being monitored with endoscopy.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-12-07
• Study First Submitted QC: 2009-12-09
• Study First Posted: 2009-12-11
• Status Verified: 2010-03
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Last Update Submitted: 2010-03-24
• Last Update Posted: 2010-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Age at least 18.
• Barrett's esophagus
• Acid suppressive therapy
• Endoscopic surveillance

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Exclusion Criteria

• Pregnancy or lactation
• Allergy to fluorescein
• Endoscopic esophagitis Los Angeles classification A to D
• Mucosal irregularity or nodules suspicious for dysplastic or cancerous lesion
• Obvious mass lesions or cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CEM	Fluorescence-aided confocal endomicroscopy guided biopsy.	Biopsies obtained with fluorescence-aided confocal endomicroscopy.
RFQ	Random four-quadrant biopsies.	Random four-quadrant biopsies.

Primary Outcome Measures

Name	Time	Method
Whether specialized columnar epithelium was detected.	At biopsy on Day 0.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States