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

Phase 2

• Conditions: Image Quality; Skin Discoloration
• Interventions: Drug: fluorescein sodium 0.05ml/kg; Drug: fluorescein sodium 0.02ml/kg; Drug: fluorescein sodium 0.01ml/kg; Drug: fluorescein sodium 0.1ml/kg

• Registration Number: NCT02519920
• Lead Sponsor: Shandong University

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2015-08-10
• Study First Posted: 2015-08-11
• Status Verified: 2015-09
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-20
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 3	fluorescein sodium 0.05ml/kg	This group patients were given dosages of fluorescein sodium 0.05ml/kg intravenous administration.
group 2	fluorescein sodium 0.02ml/kg	This group patients were given dosages of fluorescein sodium 0.02ml/kg intravenous administration.
group 1	fluorescein sodium 0.01ml/kg	This group patients were given dosages of fluorescein sodium 0.01ml/kg intravenous administration.
group 4	fluorescein sodium 0.1ml/kg	This group patients were given dosages of fluorescein sodium 0.1ml/kg intravenous administration.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China