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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cirrhotic patients with esophageal varices | 52 cirrhotic patients with esophageal varices. |
| |
| cirrhotic patients without esophageal varices | 52 cirrhotic patients without esophageal varices. |
| |
| control group | 52 healthy subjects as a control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| measuring fecal calprotectin level (microgram/gram) for predicting esophageal varices | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| comparing fecal calprotectin versus non-invasive scores for predicting esophageal varices | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rania M Elkafoury, MD | Contact | +201004672358 | rania.elkafoury@med.tanta.edu.eg | |
| Nabila A Elgazzar, MD | Contact | 00201288585733 | nabilaelgazzar@med.tanta.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Rania M Elkafoury, MD | Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University Hospitals | Recruiting | Tanta | Gharbyea | 31516 | Egypt |
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| ID | Term |
|---|---|
| D004932 | Esophageal and Gastric Varices |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006975 | Hypertension, Portal |
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|
| D008107 | Liver Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |