Non-invasive Methods and Surgical Risk Stratification in Cirrhotics Undergoing Elective Extrahepatic Surgery

Integrated University Hospital Trust of Verona

Status: Unknown

Conditions: Surgery--Complications; Advanced Chronic Liver Disease

Study type: Observational

Funder types: Other

Identifiers

NCT04615091

39512

Details and patient eligibility

About

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.

Full 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

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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