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

Image Quality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02519920
• Other study ID #: 2015SDU-QILU-G08
• Status: Recruiting
• Phase: Phase 2
• First received: August 3, 2015
• Last updated: October 19, 2015
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: September 2015
• Source: Shandong University
• Contact: Yanqing Li, PhD.MD
• Phone: 18678827666
• Email: qiluliyanqing[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardChina: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Image Quality
• Skin Discoloration

Intervention

Drug:
• fluorescein sodium 0.01ml/kg
fluorescein Sodium Dose of 0.01ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin
• fluorescein sodium 0.02ml/kg
fluorescein Sodium Dose of 0.02ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin
• fluorescein sodium 0.05ml/kg
fluorescein Sodium Dose of 0.05ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin
• fluorescein sodium 0.1ml/kg
fluorescein Sodium Dose of 0.1ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No