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

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ClinicalTrials.gov Identifier: NCT02519920
Recruitment Status : Unknown
Verified September 2015 by Yanqing Li, Shandong University.
Recruitment status was:  Recruiting
First Posted : August 11, 2015
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, 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.

Condition or disease Intervention/treatment Phase
Image Quality Skin Discoloration Drug: fluorescein sodium 0.01ml/kg Drug: fluorescein sodium 0.02ml/kg Drug: fluorescein sodium 0.05ml/kg Drug: fluorescein sodium 0.1ml/kg Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Lower Fluorescein Sodium Dose on Confocal Laser Endoscopy Image Quality and Yellow Discoloration of the Skin
Study Start Date : April 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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




Primary Outcome Measures :
  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) [ Time Frame: six months ]

Secondary Outcome Measures :
  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) [ Time Frame: six months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519920


Contacts
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Contact: Yanqing Li, PhD.MD 18678827666 ext 82169508 qiluliyanqing@gmail.com

Locations
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China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Yanqing Li, MD, PhD    86-531-82169236 ext 82169508    liyanqing@sdu.edu.cn   
Sponsors and Collaborators
Shandong University
Investigators
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Study Director: Yanqing Li, PhD.MD Department of Gastroenterology,Qilu Hospital,Shandong University

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Responsible Party: Yanqing Li, Vice president of Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT02519920     History of Changes
Other Study ID Numbers: 2015SDU-QILU-G08
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: September 2015