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
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|
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 Type :||Observational|
|Estimated Enrollment :||100 participants|
|Observational Model:||Case Control|
|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|
- diagnostic yield of targeted biopsies with high definition endoscopy using i scan virtual chromoendoscopy and acetic acid guided biopsies [ Time Frame: one year ]
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
|University of Mainz||Recruiting|
|Mainz, Germany, 55131|
|Contact: Arthur Hoffman, MD 004915111628399 firstname.lastname@example.org|
|Principal Investigator:||Arthur Hoffman, MD||Johannes Gutenberg University Mainz|