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Confocal Laserscanning Microscopy for Detection of Barretts Esophagus

Primary Purpose

Barrett Esophagus

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

confocal laser microscopy

About this trial

This is an interventional diagnostic trial for Barrett Esophagus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

2nd department of the Medical Clinic of the Technical University Munich

Outcomes

Primary Outcome Measures

diagnostic accuracy of confocal laser scanning microscopy for detection of metaplasia or neoplasia in Barrett´s esophagus

Secondary Outcome Measures

inter- and intra observer variability for confocal laser scanning microscopy

Full Information

NCT ID

NCT00449995

First Posted

February 23, 2007

Last Updated

December 23, 2008

Sponsor

Technical University of Munich

Collaborators

Charite University, Berlin, Germany, Technische Universität Dresden

1. Study Identification

Unique Protocol Identification Number

NCT00449995

Brief Title

Confocal Laserscanning Microscopy for Detection of Barretts Esophagus

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Technical University of Munich

Collaborators

Charite University, Berlin, Germany, Technische Universität Dresden

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Barrett Esophagus

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Single

Allocation

Non-Randomized

Enrollment

73 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

confocal laser microscopy

Primary Outcome Measure Information:

Title

diagnostic accuracy of confocal laser scanning microscopy for detection of metaplasia or neoplasia in Barrett´s esophagus

Secondary Outcome Measure Information:

Title

inter- and intra observer variability for confocal laser scanning microscopy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander Meining, MD

Organizational Affiliation

Technical University Munich

Official's Role

Principal Investigator

Facility Information:

Facility Name

2nd department of the Medical Clinic of the Technical University Munich

City

Munich

State/Province

Bavaria

ZIP/Postal Code

81675

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Confocal Laserscanning Microscopy for Detection of Barretts Esophagus

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