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

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-12-31

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.

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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.

Conditions

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Image Quality Skin Discoloration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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group 1

This group patients were given dosages of fluorescein sodium 0.01ml/kg intravenous administration.

Group Type EXPERIMENTAL

fluorescein sodium 0.01ml/kg

Intervention Type DRUG

fluorescein Sodium Dose of 0.01ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin

group 2

This group patients were given dosages of fluorescein sodium 0.02ml/kg intravenous administration.

Group Type EXPERIMENTAL

fluorescein sodium 0.02ml/kg

Intervention Type DRUG

fluorescein Sodium Dose of 0.02ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin

group 3

This group patients were given dosages of fluorescein sodium 0.05ml/kg intravenous administration.

Group Type EXPERIMENTAL

fluorescein sodium 0.05ml/kg

Intervention Type DRUG

fluorescein Sodium Dose of 0.05ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin

group 4

This group patients were given dosages of fluorescein sodium 0.1ml/kg intravenous administration.

Group Type ACTIVE_COMPARATOR

fluorescein sodium 0.1ml/kg

Intervention Type DRUG

fluorescein Sodium Dose of 0.1ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin

Interventions

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fluorescein sodium 0.01ml/kg

fluorescein Sodium Dose of 0.01ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin

Intervention Type DRUG

fluorescein sodium 0.02ml/kg

fluorescein Sodium Dose of 0.02ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin

Intervention Type DRUG

fluorescein sodium 0.05ml/kg

fluorescein Sodium Dose of 0.05ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin

Intervention Type DRUG

fluorescein sodium 0.1ml/kg

fluorescein Sodium Dose of 0.1ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes