Fecal Calprotectin for Prediction of Esophageal Varices in Cirrhotic Patients
NCT ID: NCT06908798
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
156 participants
OBSERVATIONAL
2024-12-01
2025-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
CROSS_SECTIONAL
Study Groups
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cirrhotic patients with esophageal varices
52 cirrhotic patients with esophageal varices.
fecal calprotectin
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 without esophageal varices
52 cirrhotic patients without esophageal varices.
fecal calprotectin
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)
control group
52 healthy subjects as a control.
fecal calprotectin
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)
Interventions
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fecal calprotectin
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)
Eligibility Criteria
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Inclusion Criteria
* Liver cirrhosis
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Tanta University
OTHER
Responsible Party
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Rania Mamdouh Elkafoury
Lecturer of Tropical Medicine
Principal Investigators
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Rania M Elkafoury, MD
Role: PRINCIPAL_INVESTIGATOR
Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
Locations
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Tanta University Hospitals
Tanta, Gharbyea, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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36264PR983/12/24
Identifier Type: -
Identifier Source: org_study_id
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