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

• Conditions: Advanced Chronic Liver Disease; Surgery--Complications

• Registration Number: NCT04615091
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

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

Study Timeline

• Study Start: 2020-08-30
• Study First Submitted: 2020-09-18
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-03
• Last Update Submitted: 2020-11-03
• Study First Posted: 2020-11-04
• Last Update Posted: 2020-11-04
• Primary Completion: 2021-10
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (37)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Medical University of Vienna; 🇦🇹 Vienna, Austria

University of Alberta Hospital; 🇨🇦 Edmonton, Canada

McGill University Health Centre; 🇨🇦 Montréal, Canada

Odense University Hospital; 🇩🇰 Odense, Denmark

University hospital of Angers; 🇫🇷 Angers, France

Hopital Jean Verdier; 🇫🇷 Bondy, France

Hôpital Jean Verdier; 🇫🇷 Bondy, France

Bordeaux University Hospital; 🇫🇷 Bordeau, France

Hôpital Beaujon; 🇫🇷 Clichy, France

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