Magnifying NBI Endoscopy for Gastric Condition

Magnifying Narrow-band Imaging for Diagnosis of H. Pylori and Precancerous Gastric Conditions: Comparison With Standard Endoscopy

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.

Study Overview

• Status: Completed
• Conditions: Gastritis H Pylori
• Intervention / Treatment: Other: Magnifying narrow-band imaging endoscopy

Detailed Description

The investigators aimed to evaluate the diagnostic efficacies of non-magnifying standard endoscopy for predicting H. pylori-infection status and precancerous gastric conditions, compared to magnifying NBI endoscopy

• Study Type: Observational
• Enrollment (Actual): 254

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Soonchunhyang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All of the patients underwent gastroscopy for peptic ulcer, gastric cancer screening in a single academic hospital.

Description

Inclusion Criteria:

• Gastroscopy can be performed
• H. pylori test and pathological analysis can be performed

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Soonchunhyang University Hospital
• Investigators: Principal Investigator: Jun-Hyung Cho, M.D., Digestive Disease Center, Soonchunhyang University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis
• Other Study ID Numbers: SCH-NBI endoscopy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No