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

Barrett`s Esophagus Clinical Trial

Official title:

Acetic Acid Guided Biopsies Compared With High Definition Endoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01442506
• Other study ID #: 837.237.09
• Status: Recruiting
• Phase: N/A
• First received: September 21, 2011
• Last updated: September 27, 2011
• Start date: April 2009
• Est. completion date: December 2011

Study information

• Verified date: September 2011
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with CLE

• patients with known Barrett's esophagus

Exclusion Criteria:

• pregnancy

• severe coagulopathy

• known malignancies

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett`s Esophagus

Intervention

Other:
• biopsies
taking biopsies
• biopsy
biopsy

Locations

Country	Name	City	State
Germany	University of Mainz	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic yield of targeted biopsies with high definition endoscopy using i scan virtual chromoendoscopy and acetic acid guided biopsies		one year	No