Evaluation of Image Quality Over Time After Injection of the fluorescein Sodium for Confocal Laser Endomicroscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, Shandong University
ClinicalTrials.gov Identifier:
NCT01042171
First received: January 4, 2010
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

Confocal laser endomicroscopy (CLE) is a newly developed endoscopic technique. The most commonly used fluorescent substance is Fluorescein sodium.The plasma half-life of fluorescein is 11 minutes. A recent test estimated that fluorescein-based CLSM(confocal laser scanning microscopy) of the upper-GI tract of pigs delivers the best contrast and image quality within the first 8 minutes after injection of fluorescein .However, despite its increasing use in clinical examination,there are no data on contrast dynamics and image quality over time after injection of the fluorescein sodium in the inspection of gastrointestinal tract of human being.


Condition
Change of Image Quality of CLE

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Image Quality Over Time After Injection of the fluorescein Sodium for Confocal Laser Endomicroscopy

Further study details as provided by Shandong University:

Primary Outcome Measures:
  • The ideal time period for the best CLE imaging when using fluorescein sodium is about 10 minutes [ Time Frame: Within the 30 minutes after injection of fluorescein ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

patients without any disease of heart,liver or kidney;patients without serious gastritis and other serious stomach lesions.

Criteria

Inclusion Criteria:

  • These subjects will include male or female aged between 18 and 60 years with indications for upper-endoscopy ,but without serious gastritis and other serious stomach lesions

Exclusion Criteria:

  • Complications such as gastric and/or duodenal peptic ulcer, stenosis
  • Esophageal, gastric or duodenal cancer or other malignancy
  • History of stomach surgery
  • A history of bronchial asthma, or known allergy to fluorescein.
  • Pregnant or breast‐feeding (for females)
  • Below 18 or above 60 years of age
  • Severe comorbidities ( e.g. such as renal failure, congestive cardiac failure, liver cirrhosis).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042171

Locations
China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, China, 250012
Sponsors and Collaborators
Shandong University
Investigators
Study Director: Yanqing Li, PhD. MD. Department of Gastroenterology, Qilu Hospital
  More Information

No publications provided

Responsible Party: Yanqing Li, Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT01042171     History of Changes
Other Study ID Numbers: 2009SDU-QILU-G07
Study First Received: January 4, 2010
Last Updated: July 17, 2012
Health Authority: China: Ethics Committee

ClinicalTrials.gov processed this record on April 14, 2014