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

Surgery--Complications Clinical Trial

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."

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04615091
• Other study ID #: 39512
• Status: Recruiting
• Start date: August 30, 2020
• Est. completion date: August 2022

Study information

• Verified date: November 2020
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: FEDERICO RAVAIOLI, MD; PhD
• Phone: +393333176759
• Email: f.ravaioli[@]unibo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 2022
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Chronic Liver Disease
• Liver Diseases
• Surgery--Complications

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna
Canada	University of Alberta Hospital	Edmonton
Canada	McGill University Health Centre	Montréal
Denmark	Odense University Hospital	Odense
France	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	Hospices Civils de Lyon Hopital Hotel Dieu	Lyon
France	Centre Hospitalier de Montpellier	Montpellier
France	hôpital Antoine-Béclère, Hôpitaux Universitaires Paris-Sud, Assistance Publique-Hôpitaux de Paris	Paris
France	Hôpital de la Pitié-Salpêtrière	Paris
France	Purpan Hospital Toulouse	Toulouse
Germany	University Hospital Leipzig	Leipzig
Hong Kong	The Chinese University of Hong Kong	Hong Kong
Italy	Clinica di Gastroenterologia ed Epatologia Ancona	Ancona
Italy	Gastroenterology Unit - Azienda Ospedaliera Universitaria Sant'Orsola - Malpighi	Bologna
Italy	Ospedale di Bolzano	Bolzano
Italy	Azienda ospedaliero-universitaria Careggi	Firenze
Italy	Policlinico di Milano	Milan
Italy	Policlinico di Modena	Modena
Italy	Gastroenterology Unit, University of Palermo	Palermo
Italy	Università Sapienza	Roma
Italy	A.O.U. Città della Salute e della Scienza di Torino	Torino
Italy	ASUGI Clinica Patologie del Fegato, Clinica Chirurgica	Trieste
Italy	Aoui Borgo Trento	Verona	VR
Korea, Republic of	Hanyang University Guri Hospital	Hanyang
Korea, Republic of	Boramae Internal Medicine	Seoul
Korea, Republic of	Yonsei University College of Medicine	Seoul
Spain	Barcelona Hepatic Hemodynamic Lab. Liver Unit. Hospital Clinic. Barcelona	Barcelona
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Madrid
Switzerland	Inselspital	Bern
Switzerland	Ente Ospedaliero Cantonale	Lugano
United Kingdom	UCL Sheila Sherlock	London
United Kingdom	Room Nottingham Digestive Diseases Centre BRU	Nottingham
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Denmark,  France,  Germany,  Hong Kong,  Italy,  Korea, Republic of,  Spain,  Switzerland,  United Kingdom, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Reverter E, Cirera I, Albillos A, Debernardi-Venon W, Abraldes JG, Llop E, Flores A, Martínez-Palli G, Blasi A, Martínez J, Turon F, García-Valdecasas JC, Berzigotti A, de Lacy AM, Fuster J, Hernández-Gea V, Bosch J, García-Pagán 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early post-surgical (at +90 days) complications after extrahepatic surgery	Complications related to the surgical procedure and/or liver disease after the extrahepatic elective surgery	90 days after surgery
Secondary	The liver-related events and overall survival at +90 days and + 360 days after extrahepatic 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	360 days after surgery