This study was to test an appropriate dose of fluorescein sodium which can provide high image quality to ensure endoscopy examination and have no yellow dye in the skin by a randomized blinded controlled trial.
Fluorescein sodium is one of the commonly used staining agents in confocal laser endoscopy, a device for in vivo real-time histological observation of the gastrointestinal mucosa. The conventional intravenous dosage of fluorescein sodium is in the range of 5ml to 10ml of 10% fluorescein. Image quality can be guaranteed with this range of fluorescein sodium, but yellow discoloration of the skin seriously influences daily life. This study was to test whether a lower dose of fluorescein sodium, which has minimal discoloration of skin, can provide satisfied image quality by a randomized blinded controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Enrollment
63
fluorescein Sodium Dose of 0.01ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin
fluorescein Sodium Dose of 0.02ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin
fluorescein Sodium Dose of 0.05ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, China
RECRUITINGDifferent ratios of high resolution CLE images among four different fluorescein sodium dose groups(0.01ml/kg,0.02ml/kg,0.05ml/kg,0.1ml/kg)
Time frame: six months
Different degrees of skin yellow dye of patients in four different fluorescein sodium dose groups(0.01ml/kg,0.02ml/kg,0.05ml/kg,0.1ml/kg)
Time frame: six months
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fluorescein Sodium Dose of 0.1ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin