Early Gastric Cancer Clinical Trial
Official title:
Evaluation of the Diagnostic Ability of White Light Endoscopy and Magnifying Endoscopy With Optical Enhancement System in Early Gastric Cancer and Intraepithelial Neoplasia: a Prospective Randomized Controlled Trial
The purpose of this study is to valuation of the diagnostic ability of white light imaging and magnifying endoscopy with optical enhancement system in early gastric cancer and intraepithelial neoplasia.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | May 1, 2022 |
Est. primary completion date | May 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients aged 18-80 years with H. pylori infection or histologically verified gastric lesions (chronic atrophic gastritis, intestinal metaplasia, GIN or EGC) - Or patients aged 40-80 years from a region with high incidence of gastric cancer - Or patients aged 40-80 years with first-degree relative of patients with gastric cancer - Or patients aged 40-80 years with high-risk factors for gastric cancer (high salt or pickle diet or smoking or heavy drinking) Exclusion Criteria: - A history of gastrectomy - Active gastrointestinal bleeding or advanced gastric carcinoma - Coagulopathy or severe underlying diseases - Pregnancy or lactation - Absence of informed consent |
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 | detection rate of GIN and EGC | The primary outcome was the detection rate of gastric intestinal metaplasia (GIM) and early gastric cancer (EGC) in a per-patient analysis. | 3 months | |
Secondary | sensitivity, specificity of diagnostic performances of GIN and EGC | 3 months | ||
Secondary | positive predictive value of diagnostic performances of GIN and EGC | 3 months | ||
Secondary | negative predictive value of diagnostic performances of GIN and EGC | 3 months | ||
Secondary | diagnostic accuracy in a per-biopsy analysis | 3 months |
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