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

Shandong University

Status and phase: Unknown; Phase 2

Conditions: Skin Discoloration; Image Quality

Treatments: Drug: fluorescein sodium 0.02ml/kg; Drug: fluorescein sodium 0.05ml/kg; Drug: fluorescein sodium 0.1ml/kg; Drug: fluorescein sodium 0.01ml/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT02519920

2015SDU-QILU-G08

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 63 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 4 patient groups

group 1

Experimental group

Description:

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

Treatment:

Drug: fluorescein sodium 0.01ml/kg

group 2

Experimental group

Description:

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

Treatment:

Drug: fluorescein sodium 0.02ml/kg

group 3

Experimental group

Description:

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

Treatment:

Drug: fluorescein sodium 0.05ml/kg

group 4

Active Comparator group

Description:

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

Treatment:

Drug: fluorescein sodium 0.1ml/kg