Fecal Calprotectin for Prediction of Esophageal Varices in Cirrhotic Patients

NCT06908798 | Recruiting

• 1 other identifier: 36264PR983/12/24
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Varices

Keywords

Fecal calprotectin; esophageal varices; liver cirrhosis

Outcome Measures

Primary Outcomes (1)

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

  through study completion, an average of 1 year

Secondary Outcomes (1)

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

  through study completion, an average of 1 year

Study Arms (3)

cirrhotic patients with esophageal varices

52 cirrhotic patients with esophageal varices.

Diagnostic Test: fecal calprotectin

cirrhotic patients without esophageal varices

52 cirrhotic patients without esophageal varices.

Diagnostic Test: fecal calprotectin

control group

52 healthy subjects as a control.

Diagnostic Test: fecal calprotectin

Interventions

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)

cirrhotic patients with esophageal varices; cirrhotic patients without esophageal varices; control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥18 years
• Liver cirrhosis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbyea, 31516, Egypt

RECRUITING

MeSH Terms

Conditions

Esophageal and Gastric Varices; Liver Cirrhosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Rania M Elkafoury, MD

  Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rania M Elkafoury, MD

CONTACT

+201004672358; rania.elkafoury@med.tanta.edu.eg

Nabila A Elgazzar, MD

CONTACT

00201288585733; nabilaelgazzar@med.tanta.edu.eg

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Tropical Medicine

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

EG (1)