Magnifying NBI Endoscopy for Gastric Condition

Gastritis H Pylori Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04489030
• Other study ID #: SCH-NBI endoscopy
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: August 31, 2020

Study information

• Verified date: September 2020
• Source: Soonchunhyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: August 31, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastritis
• Gastritis H Pylori

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	H. pylori infection status	H. pylori positivity would be assessed using rapid urease test.	1 month
Primary	Degree of chronic gastritis	Gastric atrophy and intestinal metaplasia would be evaluated on the basis of histopathological examination (updated Sydney system).	1 month