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

NCT ID: NCT01442506

Last Updated: 2011-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Specialized columnar epithelium (SCE) is considered as pathognomonic for Barrett's esophagus and can be recognized by new endoscopic techniques. Aim of the study is to test the efficacy of HD+ endoscopy in conjunction with i-scan (newly developed post processing digital filter) or chromoendoscopy (acetic acid) to diagnose Barrett's esophagus.

Patients with visible columnar lined lower esophagus (CLE) or known Barrett's esophagus are included. After standardized PPI therapy (14 days; standard dosage) patients are randomized at a 1:1 ratio to undergo either chromoendoscopy in conjunction with acetic acid application (10-15ml; 1.5%) or HD+ endoscopy in conjunction with i-scan. Mucosal surface structure within CLE is graduated according to Guelrud's classification (type 1-2: endoscopic prediction: gastric epithelium; type 3-4: Barrett's epithelium). Biopsies are taken in a targeted fashion (type 1-4) in both groups and subsequently 4-quadrant biopsies were taken. Primary outcome analysis's to investigate the diagnostic yield of the different biopsy protocols.

Conditions

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Barrett's Esophagus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Barrett

biopsies

Intervention Type OTHER

taking biopsies

biopsy

Intervention Type OTHER

biopsy

Interventions

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biopsies

taking biopsies

Intervention Type OTHER

biopsy

biopsy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients with CLE
* patients with known Barrett's esophagus

Exclusion Criteria

* pregnancy
* severe coagulopathy
* known malignancies
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Hoffman Arthur

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arthur Hoffman, MD

Role: PRINCIPAL_INVESTIGATOR

Johannes Gutenberg University Mainz

Locations

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University of Mainz

Mainz, , Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Arthur Hoffman, MD

Role: primary

[email protected]
004915111628399

References

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Hoffman A, Korczynski O, Tresch A, Hansen T, Rahman F, Goetz M, Murthy S, Galle PR, Kiesslich R. Acetic acid compared with i-scan imaging for detecting Barrett's esophagus: a randomized, comparative trial. Gastrointest Endosc. 2014 Jan;79(1):46-54. doi: 10.1016/j.gie.2013.07.013. Epub 2013 Aug 14.

Reference Type DERIVED
PMID: 23953402 (View on PubMed)

Other Identifiers

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837.237.09

Identifier Type: -

Identifier Source: org_study_id