Lower Fluorescein Sodium Dose on Confocal Laser Endoscopy Image Quality and Yellow Discoloration of the Skin

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Lower Fluorescein Sodium Dose on Confocal Laser Endoscopy Image Quality and Yellow Discoloration of the Skin

Conditions
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Image Quality, Skin Discoloration

Intervention / Treatment
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* Drug: fluorescein sodium 0.01ml/kg
* Drug: fluorescein sodium 0.02ml/kg
* Drug: fluorescein sodium 0.05ml/kg
* Drug: fluorescein sodium 0.1ml/kg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Only those with normal mucosa and minor gastritis from 18 were included. patients with aged 18 years to 80 years patients with normal mucosa and minor gastritis willing to provide informed consent Exclusion Criteria: serious coagulopathy dysfunction, severe cardiopulmonary disease, bronchial asthma, liver and kidney dysfunction, allergy to fluorescein, pregnancy women or breast feeding. patients with peptic ulcer, gastric cancer, remnant stomach, acute serious gastritis were also excluded. unwilling to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br>This group patients were given dosages of fluorescein sodium 0.01ml/kg intravenous administration. | Drug: fluorescein sodium 0.01ml/kg<br>* fluorescein Sodium Dose of 0.01ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin<br>|
| Experimental: group 2<br>This group patients were given dosages of fluorescein sodium 0.02ml/kg intravenous administration. | Drug: fluorescein sodium 0.02ml/kg<br>* fluorescein Sodium Dose of 0.02ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin<br>|
| Experimental: group 3<br>This group patients were given dosages of fluorescein sodium 0.05ml/kg intravenous administration. | Drug: fluorescein sodium 0.05ml/kg<br>* fluorescein Sodium Dose of 0.05ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin<br>|
| Active Comparator: group 4<br>This group patients were given dosages of fluorescein sodium 0.1ml/kg intravenous administration. | Drug: fluorescein sodium 0.1ml/kg<br>* fluorescein Sodium Dose of 0.1ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Different 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) |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | six months |