A Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies

Mayo Clinic

Status and phase: Terminated; Phase 4

Conditions: Barrett's Esophagus

Treatments: Other: Random four-quadrant biopsies.; Other: Fluorescence-aided confocal endomicroscopy guided biopsy.

Study type: Interventional

Funder types: Other

Identifiers

NCT01030263

08-001090

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

CEM

Experimental group

Description:

Biopsies obtained with fluorescence-aided confocal endomicroscopy.

Treatment:

Other: Fluorescence-aided confocal endomicroscopy guided biopsy.

RFQ

Other group

Description:

Random four-quadrant biopsies.

Treatment:

Other: Random four-quadrant biopsies.