Acetic Acid Guided Biopsies Compared With High Definition Endoscopy

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

Sponsors

Lead sponsor: Johannes Gutenberg University Mainz

Source Johannes Gutenberg University Mainz
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.

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.

Overall Status Unknown status
Start Date April 2009
Completion Date December 2011
Primary Completion Date December 2011
Study Type Observational
Primary Outcome
Measure Time Frame
diagnostic yield of targeted biopsies with high definition endoscopy using i scan virtual chromoendoscopy and acetic acid guided biopsies one year
Enrollment 100
Condition
Intervention

Intervention type: Other

Intervention name: biopsies

Description: taking biopsies

Arm group label: Barrett

Intervention type: Other

Intervention name: biopsy

Description: biopsy

Arm group label: Barrett

Eligibility

Sampling method: Probability Sample

Criteria:

Inclusion Criteria:

- patients with CLE

- patients with known Barrett's esophagus

Exclusion Criteria:

- pregnancy

- severe coagulopathy

- known malignancies

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Arthur Hoffman, MD Principal Investigator Johannes Gutenberg University Mainz
Location
facility status contact University of Mainz Arthur Hoffman, MD 004915111628399 [email protected]
Location Countries

Germany

Verification Date

September 2011

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Johannes Gutenberg University Mainz

Investigator full name: Hoffman Arthur

Investigator title: principal investigator

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Barrett

Study Design Info

Observational model: Case Control

Time perspective: Prospective

Source: ClinicalTrials.gov