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Recruiting Observational

Fecal Calprotectin for Prediction of Esophageal Varices in Cirrhotic Patients

NCT06908798 · tracked via the Priya Life Science Egypt tracker
Phase
Observational
Started
2024-12-01
Last updated
2025-04-03

Condition(s) studied

Esophageal Varices

Investigational drug(s) / intervention(s)

fecal calprotectin

fecal calprotectin: 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 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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • measuring fecal calprotectin level (microgram/gram) for predicting esophageal varices — through study completion, an average of 1 year

Trial sites (1)

FacilityCityRegionStatus
Tanta University Hospitals Tanta Gharbyea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06908798 on ClinicalTrials.gov ↗ ← All trials in Egypt