NCT02863965
Unknown
Not Applicable
High Definition Endoscopy and Optic Enhancement Endoscopy in Gastric Neoplasia: A Prospective Study
Shandong University1 site in 1 country200 target enrollmentMarch 2016
ConditionsGastric Neoplasia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastric Neoplasia
- Sponsor
- Shandong University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Positive predictive value of optical enhancement endoscopy in diagnosis of gastric neoplasia
- Last Updated
- 9 years ago
Overview
Brief Summary
The aim of the study is to evaluate the diagnostic value of high definition endoscopy and optic enhancement in gastric neoplasia.
Investigators
Yanqing Li
Vice president of Qilu Hospital
Shandong University
Eligibility Criteria
Inclusion Criteria
- •patients with dyspeptic symptoms and aged 40 years or older
- •or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis
- •or patients with family history of gastric cancer
Exclusion Criteria
- •presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia
- •presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding
- •inability to provide informed consent
Outcomes
Primary Outcomes
Positive predictive value of optical enhancement endoscopy in diagnosis of gastric neoplasia
Time Frame: 8 months
Sensitivity of optical enhancement endoscopy in diagnosis of gastric neoplasia
Time Frame: 8 months
Specificity of optical enhancement endoscopy in diagnosis of gastric neoplasia
Time Frame: 8 months
Negative predictive value of optical enhancement endoscopy in diagnosis of gastric neoplasia
Time Frame: 8 months
Secondary Outcomes
- The inter-observer and intra-observer agreement of optic enhancement endoscopy in gastric neoplasia(8 months)
Study Sites (1)
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