Magnifying NBI Endoscopy for Gastric Condition
Magnifying Narrow-band Imaging for Diagnosis of H. Pylori and Precancerous Gastric Conditions: Comparison With Standard Endoscopy
1 other identifier
observational
254
1 country
1
Brief Summary
Recently, the improved resolution with standard endoscopy allows the close observation of highly inflamed gastric mucosa without a magnifying view. In a previous study, the investigators established the endoscopic classification of H. pylori-infected stomach by non-magnifying standard endoscopy. One normal RAC pattern and three types of abnormal patterns were observed. Overall diagnostic accuracy for predicting H. pylori-infection was 91.6%. However, there is no comparison study predicting H. pylori-infection and precancerous gastric lesions between standard and magnifying endoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedFirst Submitted
Initial submission to the registry
July 24, 2020
CompletedFirst Posted
Study publicly available on registry
July 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedSeptember 29, 2020
September 1, 2020
3.9 years
July 24, 2020
September 28, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
H. pylori infection status
H. pylori positivity would be assessed using rapid urease test.
1 month
Degree of chronic gastritis
Gastric atrophy and intestinal metaplasia would be evaluated on the basis of histopathological examination (updated Sydney system).
1 month
Interventions
During endoscopy, gastric mucosal patterns would be examined by magnifying narrow-band imaging.
Eligibility Criteria
All of the patients underwent gastroscopy for peptic ulcer, gastric cancer screening in a single academic hospital.
You may qualify if:
- Gastroscopy can be performed
- H. pylori test and pathological analysis can be performed
You may not qualify if:
- Age \< 20 or \> 70 years
- Anemia (serum hemoglobin level \< 10 g/dL)
- Severe systemic disease
- Advanced chronic liver disease
- Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
- History of H. pylori eradication
- History of gastric surgery
- Recent history of upper gastrointestinal bleeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Soonchunhyang University Hospital
Seoul, South Korea
Biospecimen
Biospecimen would be obtained for urease test (commercial name: CLOtest) and pathological analysis.
Study Officials
- PRINCIPAL INVESTIGATOR
Jun-Hyung Cho, M.D.
Digestive Disease Center, Soonchunhyang University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 24, 2020
First Posted
July 28, 2020
Study Start
June 1, 2016
Primary Completion
April 30, 2020
Study Completion
August 31, 2020
Last Updated
September 29, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share