A Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies

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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)

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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