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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01042171

Enrollment

Registered

2010-01-05

Start date

2009-12-31

Completion date

2010-06-30

Last updated

2012-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Change of Image Quality of CLE

Brief summary

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame
The ideal time period for the best CLE imaging when using ﬂuorescein sodium is about 10 minutes	Within the 30 minutes after injection of fluorescein

Countries

China

Outcome results