Predicting Peptic Complications Using H. Pylori Serology and Gastric Ultrasound

Starting soon

Conditions studied: Peptic Ulcer Disease, HELICOBACTER PYLORI INFECTIONS, Helicobacter Pylori Infection, Peptic Ulcer, Dyspepsia

In brief

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.

Key facts

Study ID

NCT07458490

Run by

Assiut University

People needed

230

Starts

2026-04-01

Expected to finish

2027-05-01

Last updated by the study team

2026-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Patients who provide informed consent.

You may not qualify if…

• 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).
• Severe coagulopathy or bleeding disorders (INR >2.0).
• Pregnancy.
• Poor quality ultrasound images due to excessive bowel gas or obesity.
• Hemodynamically unstable patients requiring immediate intervention.
• Refusal to participate in the study.

Full record on ClinicalTrials.gov

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