Predicting Peptic Complications Using H. Pylori Serology and Gastric Ultrasound

NCT07458490 | Not Yet Recruiting

• 1 other identifier: H. pylori & US in Peptic Risk
• Study Type: observational
• Target: 230
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peptic Ulcer Disease; HELICOBACTER PYLORI INFECTIONS; Helicobacter Pylori Infection; Peptic Ulcer; Dyspepsia

Keywords

H. pylori serology; gastric ultrasound; peptic complications; Peptic Ulcer Disease; Helicobacter Pylori Infection; Peptic Ulcer Complications; Dyspepsia

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of Combined H. pylori Serology and Gastric Ultrasound

  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.

  Baseline (within 48 hours of initial assessment)

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients (aged 18 years and older) presenting to the Departments of Gastroenterology and Hepatology, Diagnostic Radiology, and General Surgery at AL-Rajhi University Hospital, Assiut University, Egypt. The population includes individuals presenting with dyspeptic symptoms (such as epigastric pain, nausea, vomiting, or heartburn), patients with suspected or confirmed peptic ulcer disease, and those presenting with acute complications like hematemesis, melena, or acute abdominal pain suggestive of perforation. Participants will be categorized into three groups: uncomplicated peptic ulcer disease, complicated peptic ulcer disease, and non-ulcer dyspepsia controls.

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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Peptic Ulcer; Dyspepsia

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer at the Public Health Department, Faculty of Medicine, Assiut University

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03