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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Johannes Gutenberg University Mainz.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hoffman Arthur, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01442506
First received: September 21, 2011
Last updated: September 27, 2011
Last verified: September 2011
  Purpose

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 Intervention
Barrett`s Esophagus
Other: biopsies
Other: biopsy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Acetic Acid Guided Biopsies Compared With High Definition Endoscopy

Resource links provided by NLM:


Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • diagnostic yield of targeted biopsies with high definition endoscopy using i scan virtual chromoendoscopy and acetic acid guided biopsies [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Barrett Other: biopsies
taking biopsies
Other: biopsy
biopsy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

patients with suspected barrettes esophagus

Criteria

Inclusion Criteria:

  • patients with CLE
  • patients with known Barrett's esophagus

Exclusion Criteria:

  • pregnancy
  • severe coagulopathy
  • known malignancies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442506

Locations
Germany
University of Mainz Recruiting
Mainz, Germany, 55131
Contact: Arthur Hoffman, MD    004915111628399    ahoff66286@aol.com   
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
Principal Investigator: Arthur Hoffman, MD Johannes Gutenberg University Mainz
  More Information

No publications provided by Johannes Gutenberg University Mainz

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffman Arthur, principal investigator, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01442506     History of Changes
Other Study ID Numbers: 837.237.09
Study First Received: September 21, 2011
Last Updated: September 27, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Johannes Gutenberg University Mainz:
acetic acid
virtual chromoendosopy

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Retinol acetate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014