H. Pylori Serology and Gastric Ultrasound Findings in Predicting Peptic Complications
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 230
- Primary Endpoint
- Diagnostic Accuracy of Combined H. pylori Serology and Gastric Ultrasound
Study Overview
Brief 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.
Detailed Description
Peptic ulcer disease (PUD) complications, such as bleeding, perforation, and obstruction, account for substantial hospital admissions and mortality. While upper gastrointestinal endoscopy remains the gold standard for diagnosing PUD, it is an invasive procedure that may not be readily available in resource-limited settings. H. pylori serology is a widely accessible non-invasive test, but its ability to predict ulcer severity or active complications remains unclear. Concurrently, abdominal ultrasound has emerged as a potential tool to evaluate gastric wall thickness and detect signs of perforation, yet data on combining it with serology is limited.
This prospective observational study aims to evaluate the diagnostic accuracy of combining H. pylori IgG serology with gastric ultrasound findings to predict peptic complications. The study will be conducted at AL-Rajhi University Hospital, Assiut University, Egypt.
All enrolled participants will undergo a standardized clinical assessment, including a detailed history of symptoms, NSAID use, and risk factors, alongside a physical examination. Upper gastrointestinal bleeding risk will be stratified using the Rockall and Glasgow-Blatchford scores.
Participants will undergo the following evaluations:
Laboratory Investigations: Quantitative measurement of H. pylori IgG antibodies via ELISA, complete blood count, coagulation profile, and inflammatory markers (CRP, ESR).
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Uncomplicated PUD
Adult patients presenting with suspected or confirmed peptic ulcer disease without acute complications.
Complicated PUD
Adult patients presenting with acute complications of peptic ulcer disease, such as hematemesis, melena, or acute abdominal pain suggestive of perforation.
Non-ulcer Dyspepsia Controls
A control group consisting of adult patients presenting with dyspeptic symptoms but without peptic ulcer disease.
Outcomes
Primary Outcomes
Diagnostic Accuracy of Combined H. pylori Serology and Gastric Ultrasound
Time Frame: Baseline (within 48 hours of initial assessment)
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mireille Maged Emile Hanna
Assistant Lecturer at the Public Health Department, Faculty of Medicine, Assiut University
Assiut University