Confocal Laserscanning Microscopy for Detection of Barretts Esophagus

Barrett Esophagus Clinical Trial

Official title:

Confocal Laserscanning Microscopy for Detection of Barretts Esophagus. A Blinded Multi-Center Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449995
• Other study ID #: 1129/04
• Status: Completed
• Phase: N/A
• First received: February 23, 2007
• Last updated: December 23, 2008
• Start date: March 2007
• Est. completion date: November 2008

Study information

• Verified date: December 2008
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Four quadrant biopsies in regular ranges is the goldstandard in monitoring this disease. The ideal situation for the endoscopist is to visualize cellular structures, which implies having microscopic imaging available. A potential candidate to fill this gap could be confocal fluorescence microscopy (Cellvizio®-GI and Mauna Kea Technologies). To compare the gold standard with the confocal fluorescence microscopy for detection of metaplastic - or intraepithelial neoplastic changes of barrett-suspicious esophageal mucosa this study has been initiated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: November 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age between 18 and 80 years

• regular esophagogastroduodenoscopy for patients with known barrett esophagus (at least stadium C0M1)

• patients presenting for endoscopic mucosectomy with intraepithelial neoplastic changes <1cm

• patients presenting with suspected intraepithelial neoplastic changes

• patients receiving acid suppressive therapy in standard dose for at least 4 weeks

Exclusion Criteria:

• no informed consent

• thrombocytopenia, quick <50%, PTT >50 sec

• patients with coronary heart disease or existent valve plasties

• women with potential pregnancy

• patients with chronic renal failure

• patients with allergies

• patients with chronic obstructive pulmonary disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Barrett Esophagus

Intervention

Procedure:
• confocal laser microscopy

Locations

Country	Name	City	State
Germany	2nd department of the Medical Clinic of the Technical University Munich	Munich	Bavaria

Sponsors (3)

Lead Sponsor	Collaborator
Technische Universität München	Charite University, Berlin, Germany, Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic accuracy of confocal laser scanning microscopy for detection of metaplasia or neoplasia in Barrett´s esophagus
Secondary	inter- and intra observer variability for confocal laser scanning microscopy