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NCT Number: NCT06908798

Fecal Calprotectin for Prediction of Esophageal Varices in Cirrhotic Patients

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.

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Key information

Conditions

Esophageal Varices Digestive System Diseases Esophageal Diseases Esophageal and Gastric Varices Fibrosis Gastrointestinal Diseases Hypertension, Portal Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University Hospitals

Tanta, Gharbyea, 31516, Egypt

Location status: Recruiting

Location contact

Dina H Ziada, MD, head of department

CONTACT

[email protected]

00201117109990

Mennat-Allah M El Sawaf, MD

SUB_INVESTIGATOR

Nabila A Elgazzar, MD

SUB_INVESTIGATOR

Rania M Elkafoury, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fecal calprotectin

Diagnostic Test

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 outcomes

  1. measuring fecal calprotectin level (microgram/gram) for predicting esophageal varices

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. comparing fecal calprotectin versus non-invasive scores for predicting esophageal varices

    Time frame: through study completion, an average of 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Nabila A Elgazzar, MD

CONTACT

[email protected]

00201288585733

Rania M Elkafoury, MD

CONTACT

[email protected]

+201004672358

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2025
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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