Predicting Peptic Complications Using H. Pylori Serology and Gastric Ultrasound

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

This observational study aims to evaluate whether combining a simple blood test (H. pylori serology) with a non-invasive abdominal ultrasound can accurately predict severe complications in patients with peptic ulcer disease (PUD). Peptic ulcer complications, such as stomach bleeding or perforation, are serious and typically require an invasive procedure called an upper endoscopy for diagnosis and treatment.

Researchers want to find out if these two non-invasive tests can be used together to create a reliable risk-scoring system. This system would help doctors quickly identify which patients are at a high risk for complications and need an urgent endoscopy, compared to those who are at a lower risk and can be safely monitored without the invasive procedure.

The study will include adult patients presenting with stomach symptoms (like pain, nausea, or heartburn), as well as those with suspected or confirmed peptic ulcer disease. Participants will provide a blood sample to check for H. pylori antibodies and undergo a standard, painless abdominal ultrasound to examine the thickness of their stomach wall. An upper gastrointestinal endoscopy will be performed if it is clinically necessary as part of the patient's standard medical care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (age ≥18 years) presenting with dyspeptic symptoms (epigastric pain, nausea, vomiting, heartburn).

Patients with suspected or confirmed peptic ulcer disease.

Patients presenting with acute complications (hematemesis, melena, acute - abdominal pain suggestive of perforation).

Patients with history of peptic ulcer disease requiring surveillance.

Disqualifiers

Previous gastric surgery (gastrectomy, vagotomy).

Active malignancy (gastric cancer, lymphoma).

Previous H. pylori eradication therapy within 4 weeks.

Current use of proton pump inhibitors (PPIs) within 2 weeks (may affect antibody levels and ultrasound findings).

Trial population

The study population consists of adult patients (aged 18 years and older) presenting to the Departments of Gastroenterology and Hepatology, Diagnostic Radiology, and General Surgery at AL-Rajhi University Hospital, Assiut University, Egypt. The population includes individuals presenting with dyspeptic symptoms (such as epigastric pain, nausea, vomiting, or heartburn), patients with suspected or confirmed peptic ulcer disease, and those presenting with acute complications like hematemesis, melena, or acute abdominal pain suggestive of perforation. Participants will be categorized into three groups: uncomplicated peptic ulcer disease, complicated peptic ulcer disease, and non-ulcer dyspepsia controls.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

230 Participants
are grouped into 3 trial groups
Group A: Uncomplicated PUD
Group B: Complicated PUD
Group C: Non-ulcer Dyspepsia Controls

Trial outcomes

Primary outcomes

1

Diagnostic Accuracy of Combined H. pylori Serology and Gastric Ultrasound

The diagnostic accuracy (including sensitivity, specificity, positive predictive value, and negative predictive value) of combining H. pylori IgG serology and gastric ultrasound scores to predict peptic ulcer complications. These non-invasive findings will be compared against the reference standard of upper gastrointestinal endoscopy.

Time frame
Baseline (within 48 hours of initial assessment)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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