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

NCT02519920 | Unknown Phase 2 DMC

• 1 other identifier: 2015SDU-QILU-G08
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Image Quality; Skin Discoloration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (4)

group 1

EXPERIMENTAL

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

Drug: fluorescein sodium 0.01ml/kg

group 2

EXPERIMENTAL

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

Drug: fluorescein sodium 0.02ml/kg

group 3

EXPERIMENTAL

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

Drug: fluorescein sodium 0.05ml/kg

group 4

ACTIVE COMPARATOR

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

Drug: fluorescein sodium 0.1ml/kg

Interventions

fluorescein sodium 0.01ml/kg DRUG

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

group 1

fluorescein sodium 0.02ml/kg DRUG

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

group 2

fluorescein sodium 0.05ml/kg DRUG

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

group 3

fluorescein sodium 0.1ml/kg DRUG

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

group 4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Interventions

Fluorescein

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Yanqing Li, PhD.MD

  Department of Gastroenterology,Qilu Hospital,Shandong University

  STUDY DIRECTOR

Central Study Contacts

Yanqing Li, PhD.MD

CONTACT

18678827666; qiluliyanqing@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Qilu Hospital

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 11, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 20, 2015

Record last verified: 2015-09

Locations

CN (1)