Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID06908798

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

Led by Tanta University · Updated on 2025-04-03

156

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

This observational study aims to assess how accurately fecal calprotectin can detect esophageal varices in Egyptian patients with liver cirrhosis. Researchers will compare fecal calprotectin levels among cirrhotic patients with and without esophageal varices, as well as healthy individuals. They will also evaluate several non-invasive scores, including APRI, FIB-4, ALBI, PALBI, and PSR, for predicting the presence and severity of esophageal varices. Participants are divided into three groups: cirrhotic patients with esophageal varices, cirrhotic patients without these varices, and healthy controls. Each participant will undergo clinical assessments including history-taking, physical examination, laboratory tests, fecal calprotectin measurement, abdominal ultrasound, and upper endoscopy. Endoscopic grading of esophageal varices will follow Paquet's classification, and various scoring systems will be calculated to compare their predictive performance against fecal calprotectin. Throughout the study, participants will provide stool samples for fecal calprotectin testing and undergo multiple evaluations such as ultrasound and endoscopy to monitor esophageal varices. Researchers will measure fecal calprotectin levels to predict varices over about one year. The study also compares fecal calprotectin with other scoring methods to determine the best non-invasive approach. Healthy volunteers and cirrhotic patients will be followed during this period to collect data for analysis.

CONDITIONS

Brief Title

Fecal Calprotectin for Prediction of Esophageal Varices in Cirrhotic Patients

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of liver cirrhosis
Not Eligible

You will not qualify if you...

  • Patients younger than 18 years
  • Presence of inflammatory bowel disease
  • Infectious gastroenteritis
  • Any malignancy
  • Current use of proton pump inhibitors or NSAID medications
  • Spontaneous bacterial peritonitis
  • Hepatic encephalopathy
  • Unwillingness to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 year

Participants provide stool samples to measure fecal calprotectin levels to help predict esophageal varices.

1 to 3 visits depending on assessment schedule

Long-term Monitoring

Duration - Up to 1 year

Participants are monitored over time to compare fecal calprotectin levels with other non-invasive scores for esophageal varices prediction.

Periodic visits as scheduled during study duration

Trial Site Locations

Total: 1 location

1

Tanta University Hospitals

Tanta, Gharbyea, Egypt, 31516

Actively Recruiting

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Research Team

R

Rania M Elkafoury, MD

N

Nabila A Elgazzar, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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