Gastric Swab for Helicobacter Pylori Detection

Not Applicable

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Diagnostic Test: swab RUT

• Registration Number: NCT05349578
• Lead Sponsor: Seoul National University Hospital

Brief Summary

A randomized controlled trial for comparing the Helicobacter pylori test using the swap method and the method using the conventional biopsy.

Detailed Description

The aim of this study is to conduct a prospective study under the hypothesis that a cotton swab method in the rapid urease test is not inferior to the conventional biopsy.

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-01
• Status Verified: 2022-04
• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-04-21
• Last Update Submitted: 2022-04-21
• Study First Posted: 2022-04-27
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Adults aged 20-80
• Patients who undergo esophagogastroduodenoscopy and need for investigation of Helicobacter pylori infection.

Exclusion Criteria

• Surgical history of any kind of gastrectomy
• Patients with contraindication of esophagogastroduodenoscopy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tissue	swab RUT	conventional RUT using biopsied tissue
Swab	swab RUT	RUT using swab

Primary Outcome Measures

Name	Time	Method
Accuracy	the same day wtih EGD	Accuracy of diagnosis for Helicobacter pylori infection

Secondary Outcome Measures

Name	Time	Method
sensitivity, false positive, false negative rate, etc.	the same day wtih EGD

Trial Locations

Locations (1)

Seoul National University; 🇰🇷 Seoul, Korea, Republic of