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OpenTrials
Completed

NCT Number: NCT04489030

Magnifying NBI Endoscopy for Gastric Condition

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.

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Key information

Conditions

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Soonchunhyang University Hospital

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnifying narrow-band imaging endoscopy

Other

During endoscopy, gastric mucosal patterns would be examined by magnifying narrow-band imaging.

Primary outcomes

  1. H. pylori infection status

    Time frame: 1 month

    H. pylori positivity would be assessed using rapid urease test.

  2. Degree of chronic gastritis

    Time frame: 1 month

    Gastric atrophy and intestinal metaplasia would be evaluated on the basis of histopathological examination (updated Sydney system).

Sponsors and collaborators

Lead sponsor

Soonchunhyang University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 28, 2020
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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