Ultrasound Prediction of Esophageal Variceal Bleeding Risk
Splenic Size and Portal Vein Diameter on Ultrasound in Predicting Esophageal Variceal Bleeding Risk
This prospective observational study aims to evaluate the accuracy of using routine abdominal ultrasound to predict the risk of esophageal variceal bleeding in adult patients with liver cirrhosis. Esophageal variceal bleeding is a serious complication of chronic liver disease. While upper gastrointestinal endoscopy is the current standard for diagnosing and grading these varices, it is an invasive procedure.
In this study, researchers will use ultrasound to measure the patient's spleen size and portal vein diameter. These non-invasive measurements will then be compared to the results of a standard upper endoscopy performed within 48 to 72 hours. The goal is to determine if these simple ultrasound measurements can reliably predict the presence, grade, and bleeding risk of esophageal varices, which could potentially reduce the need for routine invasive endoscopic screenings in the future.
Panoramica dello studio
Stato
Descrizione dettagliata
Background and Rationale:
Esophageal variceal bleeding is a life-threatening complication of portal hypertension in patients with chronic liver disease. While upper gastrointestinal endoscopy remains the gold standard for diagnosing and grading esophageal varices, it is an invasive procedure. Recent studies demonstrate that non-invasive parameters, specifically ultrasonographic measurements like portal vein diameter and splenic size, have emerged as independent predictors of variceal presence and bleeding risk. Despite these findings, there is limited data from Egyptian populations, particularly from Upper Egypt. This study aims to assess the diagnostic accuracy of these measurements and establish optimal cutoff values for non-invasive parameters in this population.
Study Design and Setting:
This is a prospective cross-sectional observational study conducted at the Department of Tropical Medicine and Gastroenterology and the Department of Diagnostic Radiology at AL-Rajhi University Hospital, Assiut University, Egypt. The study aims to recruit 165 adult patients with liver cirrhosis.
Study Procedures:
All enrolled participants will undergo the following assessments:
Clinical and Laboratory Assessment: Participants will undergo comprehensive history taking and physical examinations, alongside the calculation of Child-Pugh and Model for End-Stage Liver Disease (MELD) scores. Blood samples will be evaluated for complete blood count (focusing on platelets), liver and renal function tests, and prothrombin time/INR.
Abdominal Ultrasound: A high-resolution ultrasound using a 3.5-5 MHz convex transducer will be performed to measure the longest craniocaudal splenic diameter, splenic width and thickness, and portal vein diameter at the porta hepatis. Additional assessments include splenic vein diameter, ascites, liver echotexture, and the calculation of the platelet count/spleen diameter ratio.
Upper Gastrointestinal Endoscopy: Within 48-72 hours of the ultrasound, an endoscopy will be performed. Investigators will grade the varices (Grade I-III), assess for red color signs (indicating high bleeding risk), and document any gastric varices or portal hypertensive gastropathy.
Tipo di studio
Iscrizione (Stimato)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Adult patients (age ≥18 years) with chronic liver disease and clinical/laboratory/radiological evidence of liver cirrhosis
- Both compensated and decompensated cirrhosis (Child-Pugh classes A, B, and C)
- Patients scheduled for upper gastrointestinal endoscopy
- Patients who provide informed consent
Exclusion Criteria:
- Previous history of endoscopic variceal band ligation or sclerotherapy
- Prior surgical portosystemic shunt procedures or transjugular intrahepatic portosystemic shunt (TIPS)
- Hepatocellular carcinoma with portal vein thrombosis
- Previous splenectomy
- Patients receiving beta-blockers for variceal bleeding prophylaxis
- Poor quality ultrasound images due to obesity or ascites
- Refusal to participate in the study
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Grade of esophageal varices
Lasso di tempo: Baseline (at the time of upper gastrointestinal endoscopy, performed within 48 to 72 hours of the ultrasound examination)
|
Assessed during upper gastrointestinal endoscopy and classified according to the General Rules for Recording Endoscopic Findings: Grade I (small, straight varices), Grade II (enlarged, tortuous varices occupying <1/3 of lumen), and Grade III (large, coil-shaped varices occupying >1/3 of lumen).
|
Baseline (at the time of upper gastrointestinal endoscopy, performed within 48 to 72 hours of the ultrasound examination)
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Esophageal Variceal Bleeding
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cirrosi epatica
-
Medical College of WisconsinRitiratoModello alto per il punteggio MELD (end-stage Liver Disease).Stati Uniti