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 volunteersQualifiers
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
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Locations
Sponsors and contacts
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