Predicting Peptic Complications Using H. Pylori Serology and Gastric Ultrasound (NCT07458490) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Predicting Peptic Complications Using H. Pylori Serology and Gastric Ultrasound
230 participantsStarted 2026-04
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic Accuracy of Combined H. pylori Serology and Gastric Ultrasound
Timeframe: Baseline (within 48 hours of initial assessment)