Predicting Peptic Complications Using H. Pylori Serology and Gastric Ultrasound

Официальное название

H. Pylori Serology and Gastric Ultrasound Findings in Predicting Peptic Complications

Обзор

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.

Подробное описание

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).

Gastric Ultrasound: High-resolution transabdominal ultrasound to systematically evaluate gastric wall thickness, wall stratification, and the presence of free fluid or pneumoperitoneum. Researchers will calculate a total ultrasound score (0-9 points) based on these parameters.

Endoscopic Evaluation: High-definition white light endoscopy performed within 24-48 hours of assessment (or emergently if indicated) to document ulcer size, location, and Forrest classification. This will serve as the diagnostic reference standard.

Первичные конечные точки

• Diagnostic Accuracy of Combined H. pylori Serology and Gastric Ultrasound [Срок оценки: Baseline (within 48 hours of initial assessment)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07458490 · H. pylori & US in Peptic Risk

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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