Gastric Intestinal Metaplasia
Conditions
Brief summary
Confocal laser endomicroscopy (CLE) is a novel endoscopic system which can provide approximately 1000-fold magnification of the gastrointestinal mucosa. Previous studies have demonstrated its diagnostic value for Gastric intestinal metaplasia (GIM) with the use of a contrast agent.Recently, Cresyl violet (CV) has been used in CLE to visualize tissue architecture in human ileum, colon or myenteric plexus.No investigation has reported the characterization of GIM imaged with CLE when using CV as staining dye
Interventions
DIAGNOSTIC_TESTCresyl violet
cresyl violet is applicated at the concentration of 0.15% via a spraying catheter to visualize cellular and tissue architecture in the pCLE
Sponsors
Shandong University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients who had long-lasting upper gastrointestinal symptoms and aged 40 years or above * patients with H. pylori infection, or known GIM or atrophic gastritis
Exclusion criteria
* patients with a history of GI surgery * advanced gastric carcinoma or any other malignancy in the GI tract * acute upper GI bleeding * patients with contraindications to CLE examination, such as coagulopathy, pregnancy, breast feeding, impaired renal or liver function * patients refused to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| feasibility of CV for identifying GIM | 1 month | ratio of pCLE failure to visualize the cellular and subcellular structures |
| newly pCLE criteria with CV application for GIM | 1 month | ratio of diagnostic agreement between pCLE using CV and histopathological results |
Countries
China
Outcome results
None listed