Peptic Ulcer DiseaseNCT07458490
Predicting Peptic Complications Using H. Pylori Serology and Gastric Ultrasound
An observational study of Peptic Ulcer Disease and HELICOBACTER PYLORI INFECTIONS, run by Assiut University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Ulcer Disease, HELICOBACTER PYLORI INFECTIONS, Helicobacter Pylori Infection
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- Poor quality ultrasound images due to excessive bowel gas or obesity.
- Hemodynamically unstable patients requiring immediate intervention.
- Refusal to participate in the study.
About this study
Official title: 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.
Read the 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.
- 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
- Medical subject headings
- Peptic Ulcer, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (within 48 hours of initial assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mireille Maged Emile Hanna, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458490
- Sponsor's protocol ID
- H. pylori & US in Peptic Risk
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- H. Pylori Serology and Gastric Ultrasound Findings in Predicting Peptic Complications
- ClinicalTrials.gov ID
- NCT07458490
- Acronym / sponsor ID
- H. pylori & US in Peptic Risk
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Peptic Ulcer Disease and HELICOBACTER PYLORI INFECTIONS, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of Combined H. pylori Serology and Gastric Ultrasound (time frame: Baseline (within 48 hours of initial assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.