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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02519920

Enrollment

Registered

2015-08-11

Start date

2015-04-30

Completion date

2015-12-31

Last updated

2015-10-20

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

Conditions

Image Quality, Skin Discoloration

Brief summary

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

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.

Interventions

DRUGfluorescein sodium 0.01ml/kg

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

DRUGfluorescein sodium 0.02ml/kg

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

DRUGfluorescein sodium 0.05ml/kg

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

DRUGfluorescein sodium 0.1ml/kg

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

China

Contacts

Primary ContactYanqing Li, PhD.MD

qiluliyanqing@gmail.com18678827666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026