Clinical trial NCT04615091: Non-invasive Methods and Surgical Risk Stratification in Cirrhotics Undergoing Elective Extrahepatic Surgery
Official title: "Prognostic Role of Portal Hypertension Assessed by Non-invasive Methods to Stratify Surgical Risk in Compensated Advanced Chronic Liver Disease Patients Undergoing Elective Extrahepatic Surgery: ELASTOSURGERY STUDY."
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Chronic Liver Disease
Surgery--Complications
Keywords: liver stiffness
spleen stiffness
portal hypertension
liver cirrhosis
extrahepatic surgery
transient elastography
fibroscan
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced chronic liver disease patients who are planned an elective extrahepatic surgery (abdominal, orthopaedics and thoracic-cardiovascular surgeries)

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

Eligibility criteria: 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

Primary outcomes:
measure: Early post-surgical (at +90 days) complications after extrahepatic surgery
timeFrame: 90 days after surgery
Secondary outcomes:
measure: The liver-related events and overall survival at +90 days and + 360 days after extrahepatic surgery
timeFrame: 360 days after surgery
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Edmonton
country: Canada
facility: University of Alberta Hospital
city: Montréal
country: Canada
facility: McGill University Health Centre
city: Odense
country: Denmark
facility: Odense University Hospital
city: Angers
country: France
facility: University hospital of Angers
city: Bondy
country: France
facility: Hopital Jean Verdier
city: Bondy
country: France
facility: Hôpital Jean Verdier
city: Bordeau
country: France
facility: Bordeaux University Hospital
city: Clichy
country: France
facility: Hôpital Beaujon
city: Lyon
country: France
facility: Hospices Civils de Lyon Hopital Hotel Dieu
city: Montpellier
country: France
facility: Centre Hospitalier de Montpellier
city: Paris
country: France
facility: hôpital Antoine-Béclère, Hôpitaux Universitaires Paris-Sud, Assistance Publique-Hôpitaux de Paris
city: Paris
country: France
facility: Hôpital de la Pitié-Salpêtrière
city: Toulouse
country: France
facility: Purpan Hospital Toulouse
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
city: Verona
country: Italy
facility: Aoui Borgo Trento
state: VR
city: Ancona
country: Italy
facility: Clinica di Gastroenterologia ed Epatologia Ancona
city: Bologna
country: Italy
facility: Gastroenterology Unit - Azienda Ospedaliera Universitaria Sant'Orsola - Malpighi
city: Bolzano
country: Italy
facility: Ospedale di Bolzano
city: Firenze
country: Italy
facility: Azienda ospedaliero-universitaria Careggi
city: Milan
country: Italy
facility: Policlinico di Milano
city: Modena
country: Italy
facility: Policlinico di Modena
city: Palermo
country: Italy
facility: Gastroenterology Unit, University of Palermo
city: Roma
country: Italy
facility: Università Sapienza
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino
city: Trieste
country: Italy
facility: ASUGI Clinica Patologie del Fegato, Clinica Chirurgica
city: Hanyang
country: Korea, Republic of
facility: Hanyang University Guri Hospital
city: Seoul
country: Korea, Republic of
facility: Boramae Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
city: Barcelona
country: Spain
facility: Barcelona Hepatic Hemodynamic Lab. Liver Unit. Hospital Clinic. Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Bern
country: Switzerland
facility: Inselspital
city: Lugano
country: Switzerland
facility: Ente Ospedaliero Cantonale
city: London
country: United Kingdom
facility: UCL Sheila Sherlock
city: Nottingham
country: United Kingdom
facility: Room Nottingham Digestive Diseases Centre BRU
Study officials:
affiliation: Azienda Ospedaliera Universitaria Integrata Verona
name: ANTONIO COLECCHIA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bologna
name: DAVIDE FESTI, MD
role: STUDY_CHAIR
affiliation: University of Bologna
name: GIOVANNI MARASCO, MD; PhD
role: STUDY_CHAIR
affiliation: Azienda Ospedaliera Universitaria Integrata Verona
name: CATERINA CUSUMANO, MD
role: STUDY_CHAIR
affiliation: Azienda Ospedaliera Universitaria Integrata Verona
name: KAMELA GJINI
role: STUDY_CHAIR
affiliation: University of Bologna
name: FEDERICO RAVAIOLI, MD
role: STUDY_CHAIR
affiliation: University of Bologna
name: ELTON DAJTI, MD
role: STUDY_CHAIR
References:
citation: Uyei J, Taddei TH, Kaplan DE, Chapko M, Stevens ER, Braithwaite RS. Setting ambitious targets for surveillance and treatment rates among patients with hepatitis C related cirrhosis impacts the cost-effectiveness of hepatocellular cancer surveillance and substantially increases life expectancy: A modeling study. PLoS One. 2019 Aug 26;14(8):e0221614. doi: 10.1371/journal.pone.0221614. eCollection 2019.
citation: Newman KL, Johnson KM, Cornia PB, Wu P, Itani K, Ioannou GN. Perioperative Evaluation and Management of Patients With Cirrhosis: Risk Assessment, Surgical Outcomes, and Future Directions. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2398-2414.e3. doi: 10.1016/j.cgh.2019.07.051. Epub 2019 Jul 31.
citation: Reverter E, Cirera I, Albillos A, Debernardi-Venon W, Abraldes JG, Llop E, Flores A, Martinez-Palli G, Blasi A, Martinez J, Turon F, Garcia-Valdecasas JC, Berzigotti A, de Lacy AM, Fuster J, Hernandez-Gea V, Bosch J, Garcia-Pagan JC. The prognostic role of hepatic venous pressure gradient in cirrhotic patients undergoing elective extrahepatic surgery. J Hepatol. 2019 Nov;71(5):942-950. doi: 10.1016/j.jhep.2019.07.007. Epub 2019 Jul 19.
citation: Colecchia A, Ravaioli F, Marasco G, Colli A, Dajti E, Di Biase AR, Bacchi Reggiani ML, Berzigotti A, Pinzani M, Festi D. A combined model based on spleen stiffness measurement and Baveno VI criteria to rule out high-risk varices in advanced chronic liver disease. J Hepatol. 2018 Aug;69(2):308-317. doi: 10.1016/j.jhep.2018.04.023. Epub 2018 May 3.
citation: Colecchia A, Montrone L, Scaioli E, Bacchi-Reggiani ML, Colli A, Casazza G, Schiumerini R, Turco L, Di Biase AR, Mazzella G, Marzi L, Arena U, Pinzani M, Festi D. Measurement of spleen stiffness to evaluate portal hypertension and the presence of esophageal varices in patients with HCV-related cirrhosis. Gastroenterology. 2012 Sep;143(3):646-654. doi: 10.1053/j.gastro.2012.05.035. Epub 2012 May 27.
citation: Ma X, Wang L, Wu H, Feng Y, Han X, Bu H, Zhu Q. Spleen Stiffness Is Superior to Liver Stiffness for Predicting Esophageal Varices in Chronic Liver Disease: A Meta-Analysis. PLoS One. 2016 Nov 9;11(11):e0165786. doi: 10.1371/journal.pone.0165786. eCollection 2016.
citation: Cescon M, Colecchia A, Cucchetti A, Peri E, Montrone L, Ercolani G, Festi D, Pinna AD. Value of transient elastography measured with FibroScan in predicting the outcome of hepatic resection for hepatocellular carcinoma. Ann Surg. 2012 Nov;256(5):706-12; discussion 712-3. doi: 10.1097/SLA.0b013e3182724ce8.
citation: Marasco G, Colecchia A, Dajti E, Ravaioli F, Cucchetti A, Cescon M, Festi D. Prediction of posthepatectomy liver failure: Role of SSM and LSPS. J Surg Oncol. 2019 Mar;119(3):400-401. doi: 10.1002/jso.25345. Epub 2018 Dec 18. No abstract available.