Fecal Calprotectin for Prediction of Esophageal Varices in Cirrhotic Patients
ConditionEsophageal Varices
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTanta University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥18 years
Liver cirrhosis
Disqualifiers
Patients aged < 18 years.
Inflammatory bowel disease.
Infectious gastroenteritis.
Malignancy.
Trial 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.
Trial design
Design model
Ecologic or community
Time perspective
Cross-sectional
Treatments tested in this trial
fecal calprotectin
Diagnostic testfecal 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)
Treatment groups
156 Participants
are divided into 3 treatment groupsGroup A: cirrhotic patients with esophageal varices1 intervention
Group B: cirrhotic patients without esophageal varices1 intervention
Group C: control group1 intervention
Trial outcomes
Primary outcomes
1
measuring fecal calprotectin level (microgram/gram) for predicting esophageal varices
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
comparing fecal calprotectin versus non-invasive scores for predicting esophageal varices
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov