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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.
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
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Advanced chronic liver disease patients who are planned an elective extrahepatic surgery (abdominal, orthopaedics and thoracic-cardiovascular surgeries)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| FEDERICO RAVAIOLI, MD; PhD | Contact | +393333176759 | f.ravaioli@unibo.it | |
| ELTON DAJTI, MD | Contact | elton.dajti2@unibo.it |
| Name | Affiliation | Role |
|---|---|---|
| ANTONIO COLECCHIA, MD | Azienda Ospedaliera Universitaria Integrata Verona | Principal Investigator |
| DAVIDE FESTI, MD | University of Bologna | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | Not yet recruiting | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31449554 | Background | 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. | |
| 31376494 |
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| 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 |
| Medical University of Vienna | Not yet recruiting | Vienna | Austria |
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| University of Alberta Hospital | Not yet recruiting | Edmonton | Canada |
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| McGill University Health Centre | Not yet recruiting | Montreal | Canada |
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| Odense University Hospital | Not yet recruiting | Odense | Denmark |
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| University hospital of Angers | Not yet recruiting | Angers | France |
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| Hopital Jean Verdier | Not yet recruiting | Bondy | France |
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| Hôpital Jean Verdier | Not yet recruiting | Bondy | France |
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| Bordeaux University Hospital | Not yet recruiting | Bordeau | France |
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| Hôpital Beaujon | Not yet recruiting | Clichy | France |
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| Hospices Civils de Lyon Hopital Hotel Dieu | Not yet recruiting | Lyon | France |
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| Centre Hospitalier de Montpellier | Not yet recruiting | Montpellier | France |
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| hôpital Antoine-Béclère, Hôpitaux Universitaires Paris-Sud, Assistance Publique-Hôpitaux de Paris | Not yet recruiting | Paris | France |
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| Hôpital de la Pitié-Salpêtrière | Not yet recruiting | Paris | France |
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| Purpan Hospital Toulouse | Not yet recruiting | Toulouse | France |
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| University Hospital Leipzig | Not yet recruiting | Leipzig | Germany |
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| The Chinese University of Hong Kong | Not yet recruiting | Hong Kong | Hong Kong |
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| Aoui Borgo Trento | Recruiting | Verona | VR | 37126 | Italy |
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| Clinica di Gastroenterologia ed Epatologia Ancona | Not yet recruiting | Ancona | Italy |
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| Gastroenterology Unit - Azienda Ospedaliera Universitaria Sant'Orsola - Malpighi | Not yet recruiting | Bologna | 40138 | Italy |
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| Ospedale di Bolzano | Not yet recruiting | Bolzano | Italy |
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| Azienda ospedaliero-universitaria Careggi | Not yet recruiting | Florence | Italy |
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| Policlinico di Milano | Not yet recruiting | Milan | Italy |
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| Policlinico di Modena | Not yet recruiting | Modena | Italy |
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| Gastroenterology Unit, University of Palermo | Not yet recruiting | Palermo | Italy |
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| Università Sapienza | Not yet recruiting | Roma | Italy |
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| A.O.U. Città della Salute e della Scienza di Torino | Not yet recruiting | Torino | Italy |
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| ASUGI Clinica Patologie del Fegato, Clinica Chirurgica | Not yet recruiting | Trieste | Italy |
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| Hanyang University Guri Hospital | Not yet recruiting | Hanyang | South Korea |
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| Boramae Internal Medicine | Not yet recruiting | Seoul | South Korea |
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| Yonsei University College of Medicine | Not yet recruiting | Seoul | South Korea |
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| Barcelona Hepatic Hemodynamic Lab. Liver Unit. Hospital Clinic. Barcelona | Not yet recruiting | Barcelona | Spain |
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| Hospital Universitario Puerta de Hierro Majadahonda | Not yet recruiting | Madrid | Spain |
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| Inselspital | Not yet recruiting | Bern | Switzerland |
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| Ente Ospedaliero Cantonale | Not yet recruiting | Lugano | Switzerland |
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| UCL Sheila Sherlock | Not yet recruiting | London | United Kingdom |
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| Room Nottingham Digestive Diseases Centre BRU | Not yet recruiting | Nottingham | United Kingdom |
|
| 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. |
| 31330170 | 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. |
| 29729368 | 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. |
| 22643348 | 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. |
| 27829057 | 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. |
| 23095613 | 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. |
| 30561034 | 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. |
| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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