Probe-based Confocal Laser Endomicroscopy, the Operative Link on Gastric Intestinal Metaplasia
Conditions
Brief summary
Gastric intestinal metaplasia (GIM) is an important premalignant lesion for gastric cancer. Precisely surveillance of patients with GIM may result in early detection and improved prognosis. Though important, it is not necessary to recommend surveillance endoscopy for all patients with GIM, since the progression rate to gastric cancer within 10 years is only 1.8% in those patients.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients aged 40 years or older with Helicobacter pylori infection; * Histologically verified GIM, atrophic gastritis or dysplasia.
Exclusion criteria
* Patients with gastrectomy, acute GI bleeding and advanced gastric cancer; * Conditions unsuitable for performance of pCLE, such as coagulopathy, impaired renal function or allergy to fluorescein sodium; * Pregnancy or breastfeeding; * Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the sensitivity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM). | 6 months |
| the of specificity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM). | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| the of sensitivity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging Gastric Intestinal Metaplasia (GIM). | 6 months |
| the of specificity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging Gastric Intestinal Metaplasia (GIM). | 6 months |