Ignite Creation Date:
2024-05-05 @ 11:53 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01442506
Status:
UNKNOWN
Last Update Posted:
2011-09-28
First Post:
2011-09-21
Brief Title:
Acetic Acid Guided Biopsies Compared With High Definition Endoscopy in the Detection of Barretts Esophagus
Sponsor:
Johannes Gutenberg University Mainz
Organization:
Johannes Gutenberg University Mainz
Study Overview
Official Title:
Acetic Acid Guided Biopsies Compared With High Definition Endoscopy
Status:
UNKNOWN
Status Verified Date:
2011-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Specialized columnar epithelium SCE is considered as pathognomonic for Barretts 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 Barretts 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 11 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
Patients with visible columnar lined lower esophagus CLE are included After standardized PPI therapy 14 days standard dosage patients were randomized at a 11 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:
Specialized columnar epithelium SCE is considered as pathognomonic for Barretts 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 Barretts esophagus
Patients with visible columnar lined lower esophagus CLE or known Barretts esophagus are included After standardized PPI therapy 14 days standard dosage patients are randomized at a 11 ratio to undergo either chromoendoscopy in conjunction with acetic acid application 10-15ml 15 or HD endoscopy in conjunction with i-scan Mucosal surface structure within CLE is graduated according to Guelruds classification type 1-2 endoscopic prediction gastric epithelium type 3-4 Barretts epithelium Biopsies are taken in a targeted fashion type 1-4 in both groups and subsequently 4-quadrant biopsies were taken Primary outcome analysiss to investigate the diagnostic yield of the different biopsy protocols
Patients with visible columnar lined lower esophagus CLE or known Barretts esophagus are included After standardized PPI therapy 14 days standard dosage patients are randomized at a 11 ratio to undergo either chromoendoscopy in conjunction with acetic acid application 10-15ml 15 or HD endoscopy in conjunction with i-scan Mucosal surface structure within CLE is graduated according to Guelruds classification type 1-2 endoscopic prediction gastric epithelium type 3-4 Barretts epithelium Biopsies are taken in a targeted fashion type 1-4 in both groups and subsequently 4-quadrant biopsies were taken Primary outcome analysiss to investigate the diagnostic yield of the different biopsy protocols
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None