Gastric Swab for Helicobacter Pylori Detection

NCT ID: NCT05349578

Last Updated: 2022-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-03-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Tissue

conventional RUT using biopsied tissue

Group Type OTHER

swab RUT

Intervention Type DIAGNOSTIC_TEST

rapid urease test using swab instead of biopsied tissue

Swab

RUT using swab

Group Type EXPERIMENTAL

swab RUT

Intervention Type DIAGNOSTIC_TEST

rapid urease test using swab instead of biopsied tissue

Interventions

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swab RUT

rapid urease test using swab instead of biopsied tissue

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyunsoo Chung

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Soh H, Kim N, Moon J, Lee HM, Kim B, Cho SJ, Kim SG, Chung H. Gastric mucosal swab as an alternative to biopsy for Helicobacter pylori detection. Helicobacter. 2023 Jun;28(3):e12980. doi: 10.1111/hel.12980. Epub 2023 Apr 7.

Reference Type DERIVED
PMID: 37026561 (View on PubMed)

Other Identifiers

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2108-016-1247

Identifier Type: -

Identifier Source: org_study_id

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