High Definition Endoscopy and Optic Enhancement Endoscopy in Gastric Neoplasia: A Prospective Study
1 other identifier
observational
200
1 country
1
Brief Summary
The aim of the study is to evaluate the diagnostic value of high definition endoscopy and optic enhancement in gastric neoplasia.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 30, 2016
CompletedFirst Posted
Study publicly available on registry
August 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedAugust 11, 2016
July 1, 2016
7 months
July 30, 2016
August 8, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
Sensitivity of optical enhancement endoscopy in diagnosis of gastric neoplasia
8 months
Specificity of optical enhancement endoscopy in diagnosis of gastric neoplasia
8 months
Positive predictive value of optical enhancement endoscopy in diagnosis of gastric neoplasia
8 months
Negative predictive value of optical enhancement endoscopy in diagnosis of gastric neoplasia
8 months
Secondary Outcomes (1)
The inter-observer and intra-observer agreement of optic enhancement endoscopy in gastric neoplasia
8 months
Study Arms (1)
High definition endoscopy and optic enhancement
All the patients underwent routine preparation before the procedure. The detected lesions in high definition endoscopy were observed with optic enhancement mode. The endoscopist was required to give the real-time descriptions of surface pit patterns of the lesions, based on surface pattern classification. After that, biopsy specimens will be obtained respectively by forceps from each detected lesion recorded for histologic diagnosis.
Eligibility Criteria
Patients with dyspeptic symptoms and aged 40 years or older, or with Helicobacter pylori infection, histologically verified gastric intestinal metaplasia or atrophic gastritis, or with family history of gastric cancer
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012, China
Study Officials
- STUDY DIRECTOR
Yanqing Li, PhD. MD.
Department of Gastroenterology, Qilu Hospital, Shandong University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice president of Qilu Hospital
Study Record Dates
First Submitted
July 30, 2016
First Posted
August 11, 2016
Study Start
March 1, 2016
Primary Completion
October 1, 2016
Last Updated
August 11, 2016
Record last verified: 2016-07