Predicting Peptic Complications Using H. Pylori Serology and Gastric Ultrasound

March 4, 2026 updated by: Mireille Maged Emile Hanna, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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).

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.

Study Type

Observational

Enrollment (Estimated)

230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (within 48 hours of initial assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H. pylori & US in Peptic Risk

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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