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

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.

Study Overview

• Status: Completed
• Conditions: Change of Image Quality of CLE

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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).

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The ideal time period for the best CLE imaging when using fluorescein sodium is about 10 minutes	Within the 30 minutes after injection of fluorescein

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: January 4, 2010
• First Submitted That Met QC Criteria: January 4, 2010
• First Posted (Estimate): January 5, 2010

Study Record Updates

• Last Update Posted (Estimate): July 18, 2012
• Last Update Submitted That Met QC Criteria: July 17, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 2009SDU-QILU-G07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No