Esophageal VaricesNCT06908798
Fecal Calprotectin for Prediction of Esophageal Varices in Cirrhotic Patients
An observational study of Esophageal Varices, run by Tanta University at 1 site in Egypt.
Trial summary
The goal of this cross-sectional observational study is to evaluate the accuracy of fecal calprotectin versus non-invasive scores in assessing the presence and grading of esophageal varices in Egyptian patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Esophageal Varices
- What is being tested?
- fecal calprotectin
- How many people
- 156 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to Dec 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This cross-sectional observational study will be carried out on 156 patients who will be enrolled from the endoscopy unit in the Tropical Medicine and Infectious Diseases Department, Tanta University Hospital, Egypt. The start of research will begin in December 2024 and will end in December 2025.
Who may be able to join
- Age ≥18 years
- Liver cirrhosis
Who cannot join
- Patients aged < 18 years.
- Inflammatory bowel disease.
- Infectious gastroenteritis.
- Malignancy.
- Patients on proton pump inhibitors or NSAID.
- Patients with spontaneous bacterial peritonitis.
- Patients with hepatic encephalopathy.
- Unwilling to participate in our study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospitals
Tanta, Gharbyea, 31516
Dina H Ziada, MD, head of department, 00201117109990, dina.ziada@med.tanta.edu.eg
Rania M Elkafoury, MD
About this study
Official title: The Accuracy of Fecal Calprotectin in Detecting Esophageal Varices in Egyptian Patients With Liver Cirrhosis
The goal of this cross-sectional observational study is to evaluate the accuracy of fecal calprotectin versus non-invasive scores in assessing the presence and grading of esophageal varices in Egyptian patients.
Researchers will compare fecal calprotectin levels in cirrhotic patients with and without esophageal varices (EVs) and healthy subjects. researchers will also evaluate the performance of fecal calprotectin, AST to platelet ratio index (APRI) score, fibrosis-4 (FIB-4) score, albumin-bilirubin (ALBI) score, platelet-albumin-bilirubin (PALBI) score, and platelet-spleen diameter ratio (PSR) for predicting esophageal varices.
Participants will undergo history-taking, clinical examination, laboratory investigations, fecal calprotectin, abdominal ultrasonography, and upper endoscopy. Endoscopic grading of esophageal varices will be done using Paquet's classification. The APRI, FIB-4, ALBI, PALBI, and PSR scores will be calculated. The performance of fecal calprotectin for predicting EVs will be compared versus other non-invasive scores.
- Conditions
- Esophageal Varices
- Being tested
- fecal calprotectin
- Keywords
- Fecal calprotectin, esophageal varices, liver cirrhosis
- Medical subject headings
- Esophageal and Gastric Varices, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal calprotectinDiagnostic test
fecal calprotectin test measures calprotectin protein in a stool sample. fecal calprotectin acts as a surrogate for gastrointestinal inflammation (e.g., inflammatory bowel disease, infectious gastroenteritis, acute appendicitis, peptic ulcer disease, coeliac disease, non-steroidal anti-inflammatory drugs (NSAID)-induced enteropathy)
| Study group | Role | What they receive |
|---|---|---|
| cirrhotic patients with esophageal varices | 52 cirrhotic patients with esophageal varices. Receives: Diagnostic Test: fecal calprotectin | |
| cirrhotic patients without esophageal varices | 52 cirrhotic patients without esophageal varices. Receives: Diagnostic Test: fecal calprotectin | |
| control group | 52 healthy subjects as a control. Receives: Diagnostic Test: fecal calprotectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring fecal calprotectin level (microgram/gram) for predicting esophageal varices
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
comparing fecal calprotectin versus non-invasive scores for predicting esophageal varices
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start1 Dec 2024
- Primary completion1 Dec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal VaricesStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Mamdouh Elkafoury, Tanta University
- Investigators
- Rania M Elkafoury, MD, Principal investigator, Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908798
- Sponsor's protocol ID
- 36264PR983/12/24
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Fecal Calprotectin in Detecting Esophageal Varices in Egyptian Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT06908798
- Acronym / sponsor ID
- 36264PR983/12/24
- Conditions
- Esophageal Varices
- Keywords
- Fecal calprotectin, esophageal varices, liver cirrhosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Apr 2025 (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.
The goal of this cross-sectional observational study is to evaluate the accuracy of fecal calprotectin versus non-invasive scores in assessing the presence and grading of esophageal varices in Egyptian patients.
Researchers will compare fecal calprotectin levels in cirrhotic patients with and without esophageal varices (EVs) and healthy subjects. researchers will also evaluate the performance of fecal calprotectin, AST to platelet ratio index (APRI) score, fibrosis-4 (FIB-4) score, albumin-bilirubin (ALBI) score, platelet-albumin-bilirubin (PALBI) score, and platelet-spleen diameter ratio (PSR) for predicting esophageal varices.
Participants will undergo history-taking, clinical examination, laboratory investigations, fecal calprotectin, abdominal ultrasonography, and upper endoscopy. Endoscopic grading of esophageal varices will be done using Paquet's classification. The APRI, FIB-4, ALBI, PALBI, and PSR scores will be calculated. The performance of fecal calprotectin for predicting EVs will be compared versus other non-invasive scores.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cirrhotic patients with esophageal varices | – | Diagnostic Test: fecal calprotectin52 cirrhotic patients with esophageal varices. |
| cirrhotic patients without esophageal varices | – | Diagnostic Test: fecal calprotectin52 cirrhotic patients without esophageal varices. |
| control group | – | Diagnostic Test: fecal calprotectin52 healthy subjects as a control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This cross-sectional observational study will be carried out on 156 patients who will be enrolled from the endoscopy unit in the Tropical Medicine and Infectious Diseases Department, Tanta University Hospital, Egypt. The start of research will begin in December 2024 and will end in December 2025.
Key inclusion criteria (2 listed)
- Age ≥18 years
- Liver cirrhosis
Key exclusion criteria (8 listed)
- Patients aged < 18 years.
- Inflammatory bowel disease.
- Infectious gastroenteritis.
- Malignancy.
- Patients on proton pump inhibitors or NSAID.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fecal calprotectinfecal calprotectin test measures calprotectin protein in a stool sample. fecal calprotectin acts as a surrogate for gastrointestinal inflammation (e.g., inflammatory bowel disease, infectious gastroenteritis, acute appendicitis, peptic ulcer disease, coeliac disease, non-steroidal anti-inflammatory drugs (NSAID)-induced enteropathy) | Diagnostic test | cirrhotic patients with esophageal varices, cirrhotic patients without esophageal varices, control group |
Primary outcome
measuring fecal calprotectin level (microgram/gram) for predicting esophageal varices
Time frame: through study completion, an average of 1 year
1 secondary outcome
comparing fecal calprotectin versus non-invasive scores for predicting esophageal varices
Time frame: through study completion, an average of 1 year
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 3 Apr 2025.
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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.
Rania M Elkafoury, MD principal investigator
Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Varices, run by Tanta University at 1 site in Egypt.
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 2 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Rania M Elkafoury, MD (+201004672358, rania.elkafoury@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring fecal calprotectin level (microgram/gram) for predicting esophageal varices (time frame: through study completion, an average of 1 year). 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 3 Apr 2025.