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Recruiting NCT06908798

Fecal Calprotectin for Prediction of Esophageal Varices in Cirrhotic Patients

Observational Esophageal Varices

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: fecal calprotectin.
Who it may be relevant to
Registry conditions: Esophageal Varices. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Accuracy of Fecal Calprotectin in Detecting Esophageal Varices in Egyptian Patients With Liver Cirrhosis

Overview

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 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)

Primary outcome measures

  • measuring fecal calprotectin level (microgram/gram) for predicting esophageal varices [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (1)
  • comparing fecal calprotectin versus non-invasive scores for predicting esophageal varices [Time frame: through study completion, an average of 1 year]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Ecologic or community

Study locations

Egypt · 1 center
  • Tanta University Hospitals — Tanta

Identifiers

NCT: NCT06908798 · 36264PR983/12/24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗