Fecal Calprotectin for Prediction of Esophageal Varices in Cirrhotic Patients

Recruiting

• Conditions: Esophageal Varices

• Registration Number: NCT06908798
• Lead Sponsor: Tanta University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-27
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study First Posted: 2025-04-03
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-12-01
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 156

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
comparing fecal calprotectin versus non-invasive scores for predicting esophageal varices	through study completion, an average of 1 year

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, Gharbyea, Egypt