Fecal Calprotectin for Prediction of Esophageal Varices in Cirrhotic Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Varices
• Intervention / Treatment: Diagnostic test: fecal calprotectin

• Study Type: Observational
• Enrollment (Estimated): 156

Contacts and Locations

• Study Contact: Name: Rania M Elkafoury, MD; Phone Number: +201004672358; Email: rania.elkafoury@med.tanta.edu.eg
• Study Contact Backup: Name: Nabila A Elgazzar, MD; Phone Number: 00201288585733; Email: nabilaelgazzar@med.tanta.edu.eg

Study Locations

• Egypt
  • Gharbyea
    • Tanta, Gharbyea, Egypt, 31516
      • Recruiting
      • Tanta University Hospitals
      • Contact: Rania M Elkafoury, MD
      • Contact: Nabila A Elgazzar, MD
      • Contact: Mennat-Allah M El Sawaf, MD
      • Contact: Dina H Ziada, MD, head of department; Phone Number: 00201117109990; Email: dina.ziada@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cirrhotic patients with esophageal varices; 52 cirrhotic patients with esophageal varices.	Diagnostic test: 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)
cirrhotic patients without esophageal varices; 52 cirrhotic patients without esophageal varices.	Diagnostic test: 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)
control group; 52 healthy subjects as a control.	Diagnostic test: 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Rania M Elkafoury, MD, Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: liver cirrhosis; esophageal varices; Fecal calprotectin
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Digestive System Diseases; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Hypertension, Portal; Varicose Veins; Esophageal and Gastric Varices
• Other Study ID Numbers: 36264PR983/12/24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No