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

Shandong University

Status: Completed

Conditions: Change of Image Quality of CLE

Study type: Observational

Funder types: Other

Identifiers

NCT01042171

2009SDU-QILU-G07

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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).