Gastric Intestinal Metaplasia Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
China | Department of Gastroenterology, Qilu Hospital, Shandong University | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Shandong University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by pCLE. | 9 months | No | |
Primary | the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by WLE. | 9 months | No | |
Secondary | the overall detection rate of GIM by pCLE. | 9 months | No | |
Secondary | the overall detection rate of GIM by WLE. | 9 months | No |
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