Non-invasive Methods and Surgical Risk Stratification in Cirrhotics Undergoing Elective Extrahepatic Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Chronic Liver Disease
- Surgery- Complications
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
In the last years, the life expectancy of ACLD patients has increased due to the improvement of the therapeutic strategies of the complications of cirrhosis. .Although surgical procedures have become less invasive the mortality rate in ACLD patients undergoing extrahepatic surgery remains high. For ...
In the last years, the life expectancy of ACLD patients has increased due to the improvement of the therapeutic strategies of the complications of cirrhosis. .Although surgical procedures have become less invasive the mortality rate in ACLD patients undergoing extrahepatic surgery remains high. For these reasons, an accurate prediction of operative risk for patient-tailored surgical planning becomes crucial. Purpose of the study: To evaluate the prognostic role of portal hypertension by non- invasive methods in predicting post-operative complications in ACLD patients undergoing elective extrahepatic surgery. Study type: An international multicenter, prospective, uncontrolled observational study Study design: In cirrhotic patients undergoing extrahepatic surgery, within one month, a complete baseline evaluation is provided. Baseline evaluation (T0) includes: signature of informed consent, clinical history of liver disease, comorbidities and risk factors for hepato-biliary complications; complete laboratory tests; liver and spleen elastography (with Transient Elastography, ARFI or 2D-SWE). After surgery, each patient is evaluated at T1 (+90 days) with Elastography, laboratory tests, clinical examination and T2 (+ 365 days) by a clinical examination. Each center will prospectively collect data according to an electronic e-CFR on REDCap (Research Electronic Data Capture) system, a web application designed to support data capture for research studies in a secure manner. Study duration: The study period will last approx. 730 days, with a planned follow-up of 365 days after surgical intervention
Tracking Information
- NCT #
- NCT04615091
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: ANTONIO COLECCHIA, MD Azienda Ospedaliera Universitaria Integrata Verona Study Chair: DAVIDE FESTI, MD University of Bologna Study Chair: GIOVANNI MARASCO, MD; PhD University of Bologna Study Chair: CATERINA CUSUMANO, MD Azienda Ospedaliera Universitaria Integrata Verona Study Chair: KAMELA GJINI Azienda Ospedaliera Universitaria Integrata Verona Study Chair: FEDERICO RAVAIOLI, MD University of Bologna Study Chair: ELTON DAJTI, MD University of Bologna
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