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Fecal Calprotectin for Prediction of Esophageal Varices in Cirrhotic Patients

T

Tanta University

Status

Enrolling

Conditions

Esophageal Varices

Treatments

Diagnostic Test: fecal calprotectin

Study type

Observational

Funder types

Other

Identifiers

NCT06908798
36264PR983/12/24

Details and patient eligibility

About

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.

Enrollment

156 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

156 participants in 3 patient groups

cirrhotic patients with esophageal varices
Description:
52 cirrhotic patients with esophageal varices.
Treatment:
Diagnostic Test: fecal calprotectin
cirrhotic patients without esophageal varices
Description:
52 cirrhotic patients without esophageal varices.
Treatment:
Diagnostic Test: fecal calprotectin
control group
Description:
52 healthy subjects as a control.
Treatment:
Diagnostic Test: fecal calprotectin

Trial contacts and locations

1

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Central trial contact

Rania M Elkafoury, MD; Nabila A Elgazzar, MD

Data sourced from clinicaltrials.gov

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