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

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ClinicalTrials.gov Identifier: NCT01442506
Recruitment Status : Unknown
Verified September 2011 by Hoffman Arthur, Johannes Gutenberg University Mainz.
Recruitment status was:  Recruiting
First Posted : September 28, 2011
Last Update Posted : September 28, 2011
Sponsor:
Information provided by (Responsible Party):
Hoffman Arthur, Johannes Gutenberg University Mainz

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Barrett's Esophagus Other: biopsies Other: biopsy

Detailed Description:

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Acetic Acid Guided Biopsies Compared With High Definition Endoscopy
Study Start Date : April 2009
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Endoscopy

Groups and Cohorts
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Group/Cohort Intervention/treatment
Barrett Other: biopsies
taking biopsies

Other: biopsy
biopsy


Outcome Measures
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Primary Outcome Measures :
  1. diagnostic yield of targeted biopsies with high definition endoscopy using i scan virtual chromoendoscopy and acetic acid guided biopsies [ Time Frame: one year ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patients with suspected barrettes esophagus
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • severe coagulopathy
  • known malignancies
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01442506


Locations
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Germany
University of Mainz Recruiting
Mainz, Germany, 55131
Contact: Arthur Hoffman, MD    004915111628399    ahoff66286@aol.com   
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
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Principal Investigator: Arthur Hoffman, MD Johannes Gutenberg University Mainz
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hoffman Arthur, principal investigator, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01442506    
Other Study ID Numbers: 837.237.09
First Posted: September 28, 2011    Key Record Dates
Last Update Posted: September 28, 2011
Last Verified: September 2011
Keywords provided by Hoffman Arthur, Johannes Gutenberg University Mainz:
acetic acid
virtual chromoendosopy
Additional relevant MeSH terms:
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Barrett Esophagus
Precancerous Conditions
Neoplasms
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases