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

NCT04615091 | Unknown

• 1 other identifier: 39512
• Study Type: observational
• Target: 250
• Locations: 12 countries
• Sites: 37

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.

Conditions

Advanced Chronic Liver Disease; Surgery--Complications

Keywords

liver stiffness; spleen stiffness; portal hypertension; liver cirrhosis; extrahepatic surgery; transient elastography; fibroscan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The liver-related events and overall survival at +90 days and + 360 days after extrahepatic surgery

  360 days after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (37)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

NOT YET RECRUITING

Medical University of Vienna

Vienna, Austria

NOT YET RECRUITING

University of Alberta Hospital

Edmonton, Canada

NOT YET RECRUITING

McGill University Health Centre

Montreal, Canada

NOT YET RECRUITING

Odense University Hospital

Odense, Denmark

NOT YET RECRUITING

University hospital of Angers

Angers, France

NOT YET RECRUITING

Hopital Jean Verdier

Bondy, France

NOT YET RECRUITING

Hôpital Jean Verdier

Bondy, France

NOT YET RECRUITING

Bordeaux University Hospital

Bordeau, France

NOT YET RECRUITING

Hôpital Beaujon

Clichy, France

NOT YET RECRUITING

Hospices Civils de Lyon Hopital Hotel Dieu

Lyon, France

NOT YET RECRUITING

Centre Hospitalier de Montpellier

Montpellier, France

NOT YET RECRUITING

hôpital Antoine-Béclère, Hôpitaux Universitaires Paris-Sud, Assistance Publique-Hôpitaux de Paris

Paris, France

NOT YET RECRUITING

Hôpital de la Pitié-Salpêtrière

Paris, France

NOT YET RECRUITING

Purpan Hospital Toulouse

Toulouse, France

NOT YET RECRUITING

University Hospital Leipzig

Leipzig, Germany

NOT YET RECRUITING

The Chinese University of Hong Kong

Hong Kong, Hong Kong

NOT YET RECRUITING

Aoui Borgo Trento

Verona, VR, 37126, Italy

RECRUITING

Clinica di Gastroenterologia ed Epatologia Ancona

Ancona, Italy

NOT YET RECRUITING

Gastroenterology Unit - Azienda Ospedaliera Universitaria Sant'Orsola - Malpighi

Bologna, 40138, Italy

NOT YET RECRUITING

Ospedale di Bolzano

Bolzano, Italy

NOT YET RECRUITING

Azienda ospedaliero-universitaria Careggi

Florence, Italy

NOT YET RECRUITING

Policlinico di Milano

Milan, Italy

NOT YET RECRUITING

Policlinico di Modena

Modena, Italy

NOT YET RECRUITING

Gastroenterology Unit, University of Palermo

Palermo, Italy

NOT YET RECRUITING

Università Sapienza

Roma, Italy

NOT YET RECRUITING

A.O.U. Città della Salute e della Scienza di Torino

Torino, Italy

NOT YET RECRUITING

ASUGI Clinica Patologie del Fegato, Clinica Chirurgica

Trieste, Italy

NOT YET RECRUITING

Hanyang University Guri Hospital

Hanyang, South Korea

NOT YET RECRUITING

Boramae Internal Medicine

Seoul, South Korea

NOT YET RECRUITING

Yonsei University College of Medicine

Seoul, South Korea

NOT YET RECRUITING

Barcelona Hepatic Hemodynamic Lab. Liver Unit. Hospital Clinic. Barcelona

Barcelona, Spain

NOT YET RECRUITING

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, Spain

NOT YET RECRUITING

Inselspital

Bern, Switzerland

NOT YET RECRUITING

Ente Ospedaliero Cantonale

Lugano, Switzerland

NOT YET RECRUITING

UCL Sheila Sherlock

London, United Kingdom

NOT YET RECRUITING

Room Nottingham Digestive Diseases Centre BRU

Nottingham, United Kingdom

NOT YET RECRUITING

Related Publications (8)

• 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.

  PMID: 31449554 BACKGROUND

• 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.

  PMID: 31376494 BACKGROUND

• 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.

  PMID: 31330170 BACKGROUND

• 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.

  PMID: 29729368 BACKGROUND

• 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.

  PMID: 22643348 BACKGROUND

• 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.

  PMID: 27829057 BACKGROUND

• 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.

  PMID: 23095613 BACKGROUND

• 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.

  PMID: 30561034 BACKGROUND

MeSH Terms

Conditions

Hypertension, Portal; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ANTONIO COLECCHIA, MD

  Azienda Ospedaliera Universitaria Integrata Verona

  PRINCIPAL INVESTIGATOR

• DAVIDE FESTI, MD

  University of Bologna

  STUDY CHAIR

• GIOVANNI MARASCO, MD; PhD

  University of Bologna

  STUDY CHAIR

• CATERINA CUSUMANO, MD

  Azienda Ospedaliera Universitaria Integrata Verona

  STUDY CHAIR

• KAMELA GJINI

  Azienda Ospedaliera Universitaria Integrata Verona

  STUDY CHAIR

• FEDERICO RAVAIOLI, MD

  University of Bologna

  STUDY CHAIR

• ELTON DAJTI, MD

  University of Bologna

  STUDY CHAIR

Central Study Contacts

FEDERICO RAVAIOLI, MD; PhD

CONTACT

+393333176759; f.ravaioli@unibo.it

ELTON DAJTI, MD

CONTACT

elton.dajti2@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Gastroenterology Unit A, Borgo Trento

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: November 4, 2020
• Study Start: August 30, 2020
• Primary Completion: October 1, 2021
• Study Completion: August 1, 2022
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (11); KR (3); DE (1); ES (2); CH (2); CA (2); GB (2); HK (1); AU (1); US (1); DK (1); FR (10)