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Acetic Acid Guided Biopsies Compared With High Definition Endoscopy in the Detection of Barrett's Esophagus

NCT01442506 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2011-09-28

No results posted yet for this study

Summary

Specialized columnar epithelium (SCE) is considered as pathognomonic for Barrett's esophagus. Chromoendoscopy after local acetic acid application enables recognition of the mucosal surface architecture. The new available EPKi processor (Pentax, Japan) enables HD+ resolution above HDTV standard. Aim of the study is to test the efficacy of HD+ endoscopy in conjunction with i-Scan or acetic acid to diagnose Barrett's esophagus. The primary endpoint of the current prospective study is to investigate the diagnostic yield of virtual chromoendoscopy using the i scan function as compared to acetic acid chromoendoscopy and 4-quadrant biopsies.

Patients with visible columnar lined lower esophagus (CLE) are included. After standardized PPI therapy (14 days; standard dosage) patients were randomized at a 1:1 ratio to undergo either chromoendoscopy in conjunction with acetic acid application or i-Scan. Biopsies are taken in a targeted fashion using acetic acid or i scan and afterwards 4-quadrant biopsies are taken.

Conditions

  • Barrett's Esophagus

Interventions

OTHER

biopsies

taking biopsies

OTHER

biopsy

biopsy

Sponsors & Collaborators

  • Johannes Gutenberg University Mainz

    lead OTHER

Principal Investigators

  • Arthur Hoffman, MD · Johannes Gutenberg University Mainz

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01442506 on ClinicalTrials.gov