Confocal Laserscanning Microscopy for Detection of Barretts Esophagus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Barrett Esophagus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Interventions

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confocal laser microscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Alexander Meining, MD

Role: PRINCIPAL_INVESTIGATOR

Technical University Munich

Locations

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

Munich, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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1129/04

Identifier Type: -

Identifier Source: org_study_id