H. Pylori Serology and Gastric Ultrasound Findings in Predicting Peptic Complications
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 230
- 主要终点
- Diagnostic Accuracy of Combined H. pylori Serology and Gastric Ultrasound
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Diagnostic Accuracy of Combined H. pylori Serology and Gastric Ultrasound
时间窗: 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.
次要结局
未报告次要终点
研究者
Mireille Maged Emile Hanna
Assistant Lecturer at the Public Health Department, Faculty of Medicine, Assiut University
Assiut University