Using fecal calprotectin to predict esophageal varices in cirrhotic patients
The Accuracy of Fecal Calprotectin in Detecting Esophageal Varices in Egyptian Patients With Liver Cirrhosis
This study is testing if measuring a substance in stool can help predict if people with liver cirrhosis have esophageal varices and how serious they are.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 156 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, Gharbyea) |
| Trial ID | NCT06908798 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the accuracy of fecal calprotectin levels in predicting the presence and grading of esophageal varices in patients with liver cirrhosis. Researchers will compare fecal calprotectin levels among cirrhotic patients with and without esophageal varices, as well as healthy subjects. The study will also assess various non-invasive scoring systems, including APRI, FIB-4, ALBI, PALBI, and PSR scores, to determine their effectiveness in predicting esophageal varices. Participants will undergo clinical assessments, laboratory tests, and endoscopic evaluations to classify the varices.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years and older diagnosed with liver cirrhosis.
Not a fit: Patients with inflammatory bowel disease, infectious gastroenteritis, malignancy, or those on proton pump inhibitors or NSAIDs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for predicting esophageal varices, potentially improving patient management and outcomes.
How similar studies have performed: While the use of fecal calprotectin in this context is relatively novel, similar studies have shown promise in using non-invasive markers for assessing liver conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Liver cirrhosis Exclusion Criteria: * 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.
Where this trial is running
Tanta, Gharbyea
- Tanta University Hospitals — Tanta, Gharbyea, Egypt (Recruiting)
Study contacts
- Principal investigator: Rania M Elkafoury, MD — Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
- Study coordinator: Rania M Elkafoury, MD
- Email: rania.elkafoury@med.tanta.edu.eg
- Phone: +201004672358
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.