Barrett`s Esophagus Clinical Trial
Official title:
Acetic Acid Guided Biopsies Compared With High Definition Endoscopy
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.
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.
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Observational Model: Case Control, Time Perspective: Prospective