Biopsy, Confocal Laser Endomicroscopy, Gastric Intestinal Metaplasia, 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
DEVICEPatients in Group 1 will receive pCLE at first and WLE 2 months later
DEVICEpatients in Group 2 will receive WLE at first and pCLE 2 months later.
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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 detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by pCLE. | 9 months |
| the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by WLE. | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| the overall detection rate of GIM by pCLE. | 9 months |
| the overall detection rate of GIM by WLE. | 9 months |
Countries
China
Contacts
Primary ContactLi Yanqing, MD, PhD
Outcome results
None listed