Comparison of Confocal Laser Endomicroscopy With Standard Endoscopy for the Detection and Evaluation of Gastric Intestinal Metaplasia in a High Risk Population: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intestinal Metaplasia
- Sponsor
- Shandong University
- Enrollment
- 168
- Locations
- 1
- Primary Endpoint
- the diagnostic yield of gastric intestinal metaplasia
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to assess whether confocal laser endomicroscopy can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.
Detailed Description
Gastric intestinal metaplasia is a well-known premalignant lesions for intestinal type gastric cancer. However, present guidelines such as the updated Sydney System require multiple biopsies whereas reveal an unsatisfactory yield considering the detection and surveillance of these lesions. Confocal laser endomicroscopy is a newly developed endoscopic device that enables microscopic view of the digestive tract. Previous study has showed high sensitivity and specificity for in vivo diagnosis of gastric intestinal metaplasia using confocal laser endomicroscopy. This study aims to assess the real number of biopsies that can be reduced for the detection of gastric intestinal metaplasia using confocal laser endomicroscopy.
Investigators
Yanqing Li
Chief of the Department of Gastroenterolgoy, Qilu Hospital
Shandong University
Eligibility Criteria
Inclusion Criteria
- •40 years old ≤ age \< 80 years old
- •Patients with dyspeptic symptoms and/or with certain risk factors of gastric intestinal metaplasia
- •Able to give informed consent.
Exclusion Criteria
- •Esophageal, gastric or duodenal cancer or other malignancy
- •Known GIM or intraepithelial neoplasia in upper GI tract
- •Scheduled for endoscopic therapy
- •History of upper GI tract surgery
- •Reflux esophagitis or acute gastritis or peptic ulcers
- •Acute upper gastrointestinal bleeding
- •Coagulopathy or bleeding disorders
- •Allergy to fluorescein sodium
- •Pregnant or breast-feeding (for females)
- •Impaired renal function
Outcomes
Primary Outcomes
the diagnostic yield of gastric intestinal metaplasia
Time Frame: Seven months
Secondary Outcomes
- the biopsy number needed in each group(Seven months)