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

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.

Study Overview

• Status: Unknown
• Conditions: Image Quality; Skin Discoloration
• Intervention / Treatment: Drug: fluorescein sodium 0.01ml/kg; Drug: fluorescein sodium 0.02ml/kg; Drug: fluorescein sodium 0.05ml/kg; Drug: fluorescein sodium 0.1ml/kg

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 Type: Interventional
• Enrollment (Anticipated): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Department of Gastroenterology, Qilu Hospital, Shandong University
      • Contact: Yanqing Li, MD, PhD; Phone Number: 82169508 86-531-82169236; Email: liyanqing@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1; This group patients were given dosages of fluorescein sodium 0.01ml/kg intravenous administration.	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
Experimental: group 2; This group patients were given dosages of fluorescein sodium 0.02ml/kg intravenous administration.	Drug: fluorescein sodium 0.02ml/kg; fluorescein Sodium Dose of 0.02ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin
Experimental: group 3; This group patients were given dosages of fluorescein sodium 0.05ml/kg intravenous administration.	Drug: fluorescein sodium 0.05ml/kg; fluorescein Sodium Dose of 0.05ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin
Active Comparator: group 4; This group patients were given dosages of fluorescein sodium 0.1ml/kg intravenous administration.	Drug: fluorescein sodium 0.1ml/kg; fluorescein Sodium Dose of 0.1ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Shandong University
• Investigators: Study Director: Yanqing Li, PhD.MD, Department of Gastroenterology,QiLu Hospital,Shandong University

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: August 3, 2015
• First Submitted That Met QC Criteria: August 10, 2015
• First Posted (Estimate): August 11, 2015

Study Record Updates

• Last Update Posted (Estimate): October 20, 2015
• Last Update Submitted That Met QC Criteria: October 19, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 2015SDU-QILU-G08