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Comparison of Diagnostic Accuracy of Helicobacter pylori Detection Methods in Patients with Acute Peptic Ulcer Bleeding

Comparison of Diagnostic Accuracy of Helicobacter pylori Detection Methods in Patients with Acute Peptic Ulcer Bleeding

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20260506007
Enrollment
198
Registered
2026-05-06
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute peptic ulcer bleeding with suspected Helicobacter pylori infection Peptic ulcer, Gastrointestinal bleeding, H. pylori

Interventions

All enrolled participants will undergo H. pylori testing using the following methods: rapid urease test from gastric biopsy specimens
histology with standard staining and immunohistochemistry
stool H. pylori antigen test using a monoclonal antibody-based immunoassay
and serum IgG antibody test using ELISA.
Diagnostic
Peptic ulcer bleeding patients

Sponsors

The Gastroenterological Association of Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 years 2. Admitted as inpatients with symptoms or signs of acute upper gastrointestinal bleeding 3. Underwent upper gastrointestinal endoscopy showing peptic ulcer bleeding from a gastric or duodenal ulcer 4. Able to provide written informed consent personally or through a legally authorized representative.

Exclusion criteria

Exclusion criteria: 1. Bleeding caused by malignancy, tumor, or non-peptic ulcer lesions 2. Prior PPI use within 2 weeks or antibiotic use within 4 weeks before enrollment 3. Previous H. pylori eradication therapy; previous gastric resection surgery 4. Abnormal bleeding risk or clinical contraindication to gastric biopsy 5. Refusal or withdrawal of consent.

Design outcomes

Primary

MeasureTime frame
diagnostic accuracy of different Helicobacter pylori detection 1 day rapid urease test, histology with immunohistochemistry, stool antigen test, and serum IgG antibody, using a hierarchic composite reference standard as the reference diagnosis.

Secondary

MeasureTime frame
diagnostic yield of different H. pylori detection methods 1 day evaluate agreement between diagnostic tests; and to identify clinical or treatment-related factors associated with false-negative results

Countries

Thailand

Contacts

Public ContactArunchai Chang

Hatyai Hospital

busmdcu58@gmail.com0650979414

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026