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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06908798
Enrollment
156
Registered
2025-04-03
Start date
2024-12-01
Completion date
2025-12-31
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Varices

Keywords

Fecal calprotectin, esophageal varices, liver cirrhosis

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.

Interventions

DIAGNOSTIC_TESTfecal 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)

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
measuring fecal calprotectin level (microgram/gram) for predicting esophageal varicesthrough study completion, an average of 1 year

Secondary

MeasureTime frame
comparing fecal calprotectin versus non-invasive scores for predicting esophageal varicesthrough study completion, an average of 1 year

Countries

Egypt

Contacts

Primary ContactRania M Elkafoury, MD
rania.elkafoury@med.tanta.edu.eg+201004672358
Backup ContactNabila A Elgazzar, MD
nabilaelgazzar@med.tanta.edu.eg00201288585733

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026