Evaluation of Image Quality Over Time After Injection of the ﬂuorescein Sodium for Confocal Laser Endomicroscopy

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

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-06-30

Brief Summary

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Confocal laser endomicroscopy (CLE) is a newly developed endoscopic technique. The most commonly used fluorescent substance is Fluorescein sodium.The plasma half-life of ﬂuorescein is 11 minutes. A recent test estimated that ﬂuorescein-based CLSM(confocal laser scanning microscopy) of the upper-GI tract of pigs delivers the best contrast and image quality within the ﬁrst 8 minutes after injection of ﬂuorescein .However, despite its increasing use in clinical examination,there are no data on contrast dynamics and image quality over time after injection of the ﬂuorescein sodium in the inspection of gastrointestinal tract of human being.

Detailed Description

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Conditions

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Change of Image Quality of CLE

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* These subjects will include male or female aged between 18 and 60 years with indications for upper-endoscopy ,but without serious gastritis and other serious stomach lesions

Exclusion Criteria

* Complications such as gastric and/or duodenal peptic ulcer, stenosis
* Esophageal, gastric or duodenal cancer or other malignancy
* History of stomach surgery
* A history of bronchial asthma, or known allergy to fluorescein.
* Pregnant or breast-feeding (for females)
* Below 18 or above 60 years of age
* Severe comorbidities ( e.g. such as renal failure, congestive cardiac failure, liver cirrhosis).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Yanqing Li

Chief of the Department of Gastroenterology, Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Li, PhD. MD.

Role: STUDY_DIRECTOR

Department of Gastroenterology, Qilu Hospital

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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2009SDU-QILU-G07

Identifier Type: -

Identifier Source: org_study_id