Advanced Chronic Liver DiseaseNCT04615091
Non-invasive Methods and Surgical Risk Stratification in Cirrhotics Undergoing Elective Extrahepatic Surgery
An observational study of Advanced Chronic Liver Disease and Surgery--Complications, run by Azienda Ospedaliera Universitaria Integrata Verona at 37 sites in 12 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Chronic Liver Disease, Surgery--Complications
- How many people
- 250 participants
- Where
- 37 sitesin 12 countries
- Study dates
- 30 Aug 2020to Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced chronic liver disease patients who are planned an elective extrahepatic surgery (abdominal, orthopaedics and thoracic-cardiovascular surgeries)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
37 sites in 12 countries.
ELTON DAJTI, MD contact
37 sites in 12 countries
Italy11 sites, 11 recruiting
- Not yet recruiting
Clinica di Gastroenterologia ed Epatologia Ancona
Ancona
Luca Maroni, l.maroni@staff.univpm.it
- Not yet recruiting
Gastroenterology Unit - Azienda Ospedaliera Universitaria Sant'Orsola - Malpighi
Bologna, 40138
Amanda Vestito, MD, amanda.vestito@aosp.bo.it
Elton Dajti, MD, elton.dajti@studio.unibo.it
- Not yet recruiting
Ospedale di Bolzano
Bolzano
Andrea Mega, andreamega@hotmail.com
- Not yet recruiting
Azienda ospedaliero-universitaria Careggi
Florence
Fabio Marra, fabio.marra@unifi.it
- Not yet recruiting
Policlinico di Milano
Milan
Mirella Fraquelli, mfraquelli@yahoo.it
- Not yet recruiting
Policlinico di Modena
Modena
Filippo Schepis, fschepis@unimore.it
- Not yet recruiting
Gastroenterology Unit, University of Palermo
Palermo
Vincenza Calvaruso, vincenza.calvaruso@unipa.it
- Not yet recruiting
Università Sapienza
Roma
Domenico Alvaro, domenico.alvaro@uniroma1.it
- Not yet recruiting
A.O.U. Città della Salute e della Scienza di Torino
Torino
Giorgio Maria Saracco, giorgiomaria.saracco@unito.it
- Not yet recruiting
ASUGI Clinica Patologie del Fegato, Clinica Chirurgica
Trieste
Saveria Lory Crocè, lcroce@units.it
- Recruiting
Aoui Borgo Trento
Verona, VR, 37126
ANTONIO COLECCHIA, MD, 0458122310, antonio.colecchia@aovr.veneto.it
CATERINA CUSUMANO, MD, 0458122310, caterina.cusumano@aovr.veneto.it
France10 sites, 10 recruiting
- Not yet recruiting
University hospital of Angers
Angers
Paul Calès, paul.cales@univ-angers.fr
- Not yet recruiting
Hopital Jean Verdier
Bondy
Pierre Nahon, pierre.nahon@jvr.aphp.fr
- Not yet recruiting
Hôpital Jean Verdier
Bondy
Nathalie Ganne-Carriè, nathalie.ganne@jvr.aphp.fr
- Not yet recruiting
Bordeaux University Hospital
Bordeau
Victor De Ledinghen, victor.deledinghen@chu-bordeaux.fr
- Not yet recruiting
Hôpital Beaujon
Clichy
Pierre Emmanuel Rautou, pierre-emmanuel.rautou@inserm.fr
- Not yet recruiting
Hospices Civils de Lyon Hopital Hotel Dieu
Lyon
Francois Bailly, francois.bailly@chu-lyon.fr
- Not yet recruiting
Centre Hospitalier de Montpellier
Montpellier
Christophe Cassinotto, christophe.cassinotto@chu-bordeaux.fr
- Not yet recruiting
hôpital Antoine-Béclère, Hôpitaux Universitaires Paris-Sud, Assistance Publique-Hôpitaux de Paris
Paris
Gabriel Perlemuter, gabriel.perlemuter@aphp.fr
- Not yet recruiting
Hôpital de la Pitié-Salpêtrière
Paris
Dominique Thabut, dominique.thabut@aphp.fr
- Not yet recruiting
Purpan Hospital Toulouse
Toulouse
Christophe Bureau, bureau.c@chu-toulouse.fr
South Korea3 sites, 3 recruiting
- Not yet recruiting
Hanyang University Guri Hospital
Hanyang
Yongsoo Kim
- Not yet recruiting
Boramae Internal Medicine
Seoul
Won Kim, kimwon@snuh.org
- Not yet recruiting
Yonsei University College of Medicine
Seoul
Seung Up Kim, ksukorea@yuhs.ac
Canada2 sites, 2 recruiting
- Not yet recruiting
University of Alberta Hospital
Edmonton
Juan Abraldes, juan.g.abraldes@ualberta.ca
- Not yet recruiting
McGill University Health Centre
Montreal
Giada Sebastiani, giada.sebastiani@mcgill.ca
Spain2 sites, 2 recruiting
- Not yet recruiting
Barcelona Hepatic Hemodynamic Lab. Liver Unit. Hospital Clinic. Barcelona
Barcelona
Juan Carlos Garcia-Pagan, jcgarcia@clinic.cat
- Not yet recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Madrid
José Luís Calleja Panero, joseluis.calleja@uam.es
Switzerland2 sites, 2 recruiting
- Not yet recruiting
Inselspital
Bern
Annalisa Berzigotti, annalisa.berzigotti@insel.ch
- Not yet recruiting
Ente Ospedaliero Cantonale
Lugano
Andrea De Gottardi, andrea.degottardi@eoc.ch
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
UCL Sheila Sherlock
London
Massimo Pinzani, m.pinzani@ucl.ac.uk
- Not yet recruiting
Room Nottingham Digestive Diseases Centre BRU
Nottingham
Neil Guha, neil.guha@nottingham.ac.uk
United States1 site, 1 recruiting
- Not yet recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06510
Guadalupe Garcia-Tsao, guadalupe.garcia-tsao@yale.edu
Austria1 site, 1 recruiting
- Not yet recruiting
Medical University of Vienna
Vienna
Thomas Reiberger, thomas.reiberger@meduniwien.ac.at
Denmark1 site, 1 recruiting
- Not yet recruiting
Odense University Hospital
Odense
Maja Thiele, maja.thiele@rsyd.dk
Germany1 site, 1 recruiting
- Not yet recruiting
University Hospital Leipzig
Leipzig
Thomas Karlas, thomas.karlas@medizin.uni-leipzig.de
Hong Kong1 site, 1 recruiting
- Not yet recruiting
The Chinese University of Hong Kong
Hong Kong
Grace Wong, wonglaihung@cuhk.edu.hk
About this study
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."
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.
Read the 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
- Keywords
- liver stiffness, spleen stiffness, portal hypertension, liver cirrhosis, extrahepatic surgery, transient elastography, fibroscan
- Medical subject headings
- Hypertension, Portal, Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days after surgery
Secondary outcomes (1)
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
Measured: 360 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start30 Aug 2020
- Primary completionOct 2021 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Advanced Chronic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Colecchia, Azienda Ospedaliera Universitaria Integrata Verona
- Investigators
- ANTONIO COLECCHIA, MD, Principal investigator, Azienda Ospedaliera Universitaria Integrata VeronaDAVIDE FESTI, MD, Study chair, University of BolognaGIOVANNI MARASCO, MD; PhD, Study chair, University of BolognaCATERINA CUSUMANO, MD, Study chair, Azienda Ospedaliera Universitaria Integrata VeronaKAMELA GJINI, Study chair, Azienda Ospedaliera Universitaria Integrata VeronaFEDERICO RAVAIOLI, MD, Study chair, University of BolognaELTON DAJTI, MD, Study chair, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615091
- Sponsor's protocol ID
- 39512
- Status last verified
- Nov 2020
- First submitted
- 18 Sep 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31449554Newman 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.
PubMed 31376494Reverter 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.
PubMed 31330170Colecchia 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.
PubMed 29729368Colecchia 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.
PubMed 22643348Ma 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.
PubMed 27829057Cescon 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.
PubMed 23095613Marasco 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.
PubMed 30561034
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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."
- ClinicalTrials.gov ID
- NCT04615091
- Acronym / sponsor ID
- 39512
- Keywords
- liver stiffness, spleen stiffness, portal hypertension, liver cirrhosis, extrahepatic surgery, transient elastography, fibroscan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced chronic liver disease patients who are planned an elective extrahepatic surgery (abdominal, orthopaedics and thoracic-cardiovascular surgeries)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early post-surgical (at +90 days) complications after extrahepatic surgery
Time frame: 90 days after surgery
Complications related to the surgical procedure and/or liver disease after the extrahepatic elective surgery
1 secondary outcome
The liver-related events and overall survival at +90 days and + 360 days after extrahepatic surgery
Time frame: 360 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Background: PubMed 31449554Uyei 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.
- Background: PubMed 31376494Newman 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.
- Background: PubMed 31330170Reverter 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.
- Background: PubMed 29729368Colecchia 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.
- Background: PubMed 22643348Colecchia 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.
- Background: PubMed 27829057Ma 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.
- Background: PubMed 23095613Cescon 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.
- Background: PubMed 30561034Marasco 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ELTON DAJTI, MD contact
ANTONIO COLECCHIA, MD principal investigator
Azienda Ospedaliera Universitaria Integrata Verona
DAVIDE FESTI, MD study chair
University of Bologna
GIOVANNI MARASCO, MD; PhD study chair
University of Bologna
37 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Chronic Liver Disease and Surgery--Complications, run by Azienda Ospedaliera Universitaria Integrata Verona at 37 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Italy, France, South Korea, Canada, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact FEDERICO RAVAIOLI, MD; PhD (+393333176759, f.ravaioli@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early post-surgical (at +90 days) complications after extrahepatic surgery (time frame: 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04615091, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.