Advanced Chronic Liver Disease, Surgery--Complications
Conditions
Keywords
liver stiffness, spleen stiffness, portal hypertension, liver cirrhosis, extrahepatic surgery, transient elastography, fibroscan
Brief summary
The ELASTO-SURGERY study aims to evaluate the prognostic role of portal hypertension evaluated by non-invasive methods in predicting post-operative morbidity (at 90 days) and mortality (at 365 days) in patients with advanced chronic liver disease undergoing elective extrahepatic surgery.
Detailed 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 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
Interventions
None listed
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 yrs; * Advanced chronic liver disease (LSM\>10 kPa) * Any etiology (viral, metabolic, alcoholic, cholestatic and autoimmune); * Elective extrahepatic surgery planned within three months and requiring regional or general anaesthesia; * Patients are willing and able to give informed consent
Exclusion criteria
* Presence of hepatic decompensation at the time of informed consent or previous events of hepatic decompensation during the last three months before enrollment. * Presence of portal vein thrombosis * Previous placement of TIPS, * Prior liver transplantation, * Surgical resection or shunt. * Presence of active HCC that needed treatment at the time of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early post-surgical (at +90 days) complications after extrahepatic surgery | 90 days after surgery | Complications related to the surgical procedure and/or liver disease after the extrahepatic elective surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The liver-related events and overall survival at +90 days and + 360 days after extrahepatic surgery | 360 days after surgery | Liver-related events (decompensation, TIPS placement, liver transplantation) or death (liver e non-liver related) at 90 days 360 days from the elective extra-hepatic surgery |
Countries
Austria, Canada, Denmark, France, Germany, Hong Kong, Italy, South Korea, Spain, Switzerland, United Kingdom, United States
Contacts
Primary ContactFEDERICO RAVAIOLI, MD; PhD
Backup ContactELTON DAJTI, MD
Outcome results
None listed