Non-invasive Methods and Surgical Risk Stratification in Cirrhotics Undergoing Elective Extrahepatic Surgery
- Conditions
- Advanced Chronic Liver DiseaseSurgery--Complications
- Registration Number
- NCT04615091
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
- 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
- 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)
Hospices Civils de Lyon Hopital Hotel Dieu
馃嚝馃嚪Lyon, France
University hospital of Angers
馃嚝馃嚪Angers, France
H么pital Jean Verdier
馃嚝馃嚪Bondy, France
Centre Hospitalier de Montpellier
馃嚝馃嚪Montpellier, France
Medical University of Vienna
馃嚘馃嚬Vienna, Austria
Yale New Haven Hospital
馃嚭馃嚫New Haven, Connecticut, United States
H么pital Beaujon
馃嚝馃嚪Clichy, France
Clinica di Gastroenterologia ed Epatologia Ancona
馃嚠馃嚬Ancona, Italy
Gastroenterology Unit - Azienda Ospedaliera Universitaria Sant'Orsola - Malpighi
馃嚠馃嚬Bologna, Italy
Policlinico di Milano
馃嚠馃嚬Milan, Italy
University of Alberta Hospital
馃嚚馃嚘Edmonton, Canada
Hopital Jean Verdier
馃嚝馃嚪Bondy, France
h么pital Antoine-B茅cl猫re, H么pitaux Universitaires Paris-Sud, Assistance Publique-H么pitaux de Paris
馃嚝馃嚪Paris, France
McGill University Health Centre
馃嚚馃嚘Montr茅al, Canada
University Hospital Leipzig
馃嚛馃嚜Leipzig, Germany
H么pital de la Piti茅-Salp锚tri猫re
馃嚝馃嚪Paris, France
Purpan Hospital Toulouse
馃嚝馃嚪Toulouse, France
Azienda ospedaliero-universitaria Careggi
馃嚠馃嚬Firenze, Italy
A.O.U. Citt脿 della Salute e della Scienza di Torino
馃嚠馃嚬Torino, Italy
Ospedale di Bolzano
馃嚠馃嚬Bolzano, Italy
Gastroenterology Unit, University of Palermo
馃嚠馃嚬Palermo, Italy
Policlinico di Modena
馃嚠馃嚬Modena, Italy
Universit脿 Sapienza
馃嚠馃嚬Roma, Italy
Odense University Hospital
馃嚛馃嚢Odense, Denmark
Bordeaux University Hospital
馃嚝馃嚪Bordeau, France
Aoui Borgo Trento
馃嚠馃嚬Verona, VR, Italy
Hanyang University Guri Hospital
馃嚢馃嚪Hanyang, Korea, Republic of
ASUGI Clinica Patologie del Fegato, Clinica Chirurgica
馃嚠馃嚬Trieste, Italy
Boramae Internal Medicine
馃嚢馃嚪Seoul, Korea, Republic of
Inselspital
馃嚚馃嚟Bern, Switzerland
Barcelona Hepatic Hemodynamic Lab. Liver Unit. Hospital Clinic. Barcelona
馃嚜馃嚫Barcelona, Spain
UCL Sheila Sherlock
馃嚞馃嚙London, United Kingdom
Room Nottingham Digestive Diseases Centre BRU
馃嚞馃嚙Nottingham, United Kingdom
Ente Ospedaliero Cantonale
馃嚚馃嚟Lugano, Switzerland
Yonsei University College of Medicine
馃嚢馃嚪Seoul, Korea, Republic of
Hospital Universitario Puerta de Hierro Majadahonda
馃嚜馃嚫Madrid, Spain
The Chinese University of Hong Kong
馃嚟馃嚢Hong Kong, Hong Kong