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Clinical Trials/NCT02863965
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

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.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
October 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shandong University
Responsible Party
Principal Investigator
Principal Investigator

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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