Dragon 1 Protocol Manuscript: Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization (PVE/HVE) to Accelerate Future Liver Remnant (FLR) Hypertrophy
CardioVascular and Interventional Radiology, vol. 45, pp. 1391–1398
Abstract
STUDY PURPOSE: The DRAGON 1 trial aims to assess training, implementation, safety and feasibility of combined portal- and hepatic-vein embolization (PVE/HVE) to accelerate future liver remnant (FLR) hypertrophy in patients with borderline resectable colorectal cancer liver metastases. METHODS: The DRAGON 1 trial is a worldwide multicenter prospective single arm trial. The primary endpoint is a composite of the safety of PVE/HVE, 90-day mortality, and one year accrual monitoring of each participating center. Secondary endpoints include: feasibility of resection, the used PVE and HVE techniques, FLR-hypertrophy, liver function (subset of centers), overall survival, and disease-free survival. All complications after the PVE/HVE procedure are documented. Liver volumes will be measured at week 1 and if applicable at week 3 and 6 after PVE/HVE and follow-up visits will be held at 1, 3, 6, and 12 months after the resection. RESULTS: Not applicable. CONCLUSION: DRAGON 1 is a prospective trial to assess the safety and feasibility of PVE/HVE. Participating study centers will be trained, and procedures standardized using Work Instructions (WI) to prepare for the DRAGON 2 randomized controlled trial. Outcomes should reveal the accrual potential of centers, safety profile of combined PVE/HVE and the effect of FLR-hypertrophy induction by PVE/HVE in patients with CRLM and a small FLR. TRIAL REGISTRATION: Clinicaltrials.gov: NCT04272931 (February 17, 2020). Toestingonline.nl: NL71535.068.19 (September 20, 2019).
Authors 94
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Remon Korenblik corresponding
Maastricht University Medical Centre · Maastricht University
Affiliation as printed
Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands. remon.korenblik@mumc.nl
GROW School for Oncology and Developmental Biology, Maastricht University, Maastricht Universiteitssingel 40 room 5.452, 6229 ET, Maastricht, The Netherlands. remon.korenblik@mumc.nl
GROW School for Oncology and Developmental Biology, Maastricht University, Maastricht Universiteitssingel 40 room 5.452, 6229 ET, Maastricht, The Netherlands
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Maastricht University Medical Centre · Maastricht University
Affiliation as printed
Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands
GROW School for Oncology and Developmental Biology, Maastricht University, Maastricht Universiteitssingel 40 room 5.452, 6229 ET, Maastricht, The Netherlands
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Affiliation as printed
Department of Surgery, Ospedale San Raffaele, Milan, Italy
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Fondazione Poliambulanza Istituto Ospedaliero
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Department of Surgery, Fondazione Poliambulanza, Brescia, Italy
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Affiliation as printed
Deparment of Radiology, University Hospital, Linköping, Sweden
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Rush University Medical Center
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Department of Radiology, Rush University Medical Center, Chicago, USA
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Affiliation as printed
Department of Radiology, Maxima Medisch Centrum, Eindhoven, The Netherlands
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Affiliation as printed
Department of Radiology, Clinic Favoriten, Vienna, Austria
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Royal Bournemouth Hospital · Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Affiliation as printed
Department of Radiology, Bournemouth and Christuchurch, The Royal Bournemouth and Christchurch Hospitals, Bournemouth and Christuchurch, UK
Department of Radiology, Bournemouth and Christuchurch, The Royal Bournemouth and Christchurch Hospitals, Bournemouth and Christuchurch, UK
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Affiliation as printed
Department of Surgery, CHU UCLouvain Namur, Namur, Belgium
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Affiliation as printed
Department of Surgery, Biomedical and Clinical Sciences, Linköping University Hospital, Linköping, Sweden
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University Medical Center Groningen
Affiliation as printed
Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands
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Maastricht University Medical Centre · Maastricht University
Affiliation as printed
Deparment of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, The Netherlands
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University Medical Center Groningen
Affiliation as printed
Department of Radiology, University Medical Center Groningen, Groningen, The Netherlands
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University Medical Center Utrecht
Affiliation as printed
Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands
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Affiliation as printed
Department of General and Visceral Surgery, Cantonal Hospital Winterthur, Winterthur, Switzerland
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University Medical Center Utrecht
Affiliation as printed
Department of Radiology, University Medical Center Utrecht, Utrecht, The Netherlands
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Affiliation as printed
Department of Radiology, University Hospital Aachen, Aachen, Germany
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University Hospital Heidelberg
Affiliation as printed
Department of Surgery, University Hospital Heidelberg, Heidelberg, Germany
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Memorial Sloan Kettering Cancer Center
Affiliation as printed
Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, USA
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IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola
Affiliation as printed
Department of Radiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Sant'Orsola-Malpighi Hospital, Bologna, Italy
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Affiliation as printed
Department of Radiology, University Hospital Oslo, Oslo, Norway
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Affiliation as printed
Department of Surgery, Aintree University Hospitals NHS, Liverpool, UK
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University Hospital Heidelberg
Affiliation as printed
Department of Radiology, University Hospital Heidelberg, Heidelberg, Germany
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Hospital Universitari de Girona Doctor Josep Trueta
Affiliation as printed
Department of Radiology, University Hospital Dr. Josep Trueta de Girona, Girona, Spain
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Affiliation as printed
Department of Surgery, Royal Prince Alfred Hospital, Camperdown, Australia
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Monash Medical Centre · Monash Health
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Department of Surgery, Monash Health, Clayton, Australia
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Hospital Universitari Germans Trias i Pujol
Affiliation as printed
Department of Surgery, University Hospital Germans Trias I Pujol, Badalona, Spain
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Affiliation as printed
Department of Radiology, Aintree University Hospitals NHS, Liverpool, UK
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Monash Medical Centre · Monash Health
Affiliation as printed
Department of Radiology, Monash Health, Clayton, Australia
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Affiliation as printed
Department of Radiology, Ospedale San Raffaele, Milan, Italy
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Affiliation as printed
Department of Radiology, CHU UCLouvain Namur, Namur, Belgium
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Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers
Affiliation as printed
Department of Radiology, Amsterdam University Medical Centers Location AMC, Amsterdam, The Netherlands
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Karolinska University Hospital
Affiliation as printed
Department of Radiology, Karolinska University Hospital, Stockholm, Sweden
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Centre Hospitalier Universitaire de Liège
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Department of Surgery, CHU de Liège, Liège, Belgium
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Affiliation as printed
Department of Surgery, Aintree University Hospitals NHS, Liverpool, UK
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Affiliation as printed
Department of Surgery, CHU UCLouvain Namur, Namur, Belgium
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Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers
Affiliation as printed
Department of Surgery, Amsterdam University Medical Centers Location AMC, Amsterdam, The Netherlands
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Affiliation as printed
Department of Surgery, Royal Prince Alfred Hospital, Camperdown, Australia
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Affiliation as printed
Department of Surgery, Hospital Clínic de Barcelona, Barcelona, Spain
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Affiliation as printed
Department of Surgery, University Hospital Oslo, Oslo, Norway
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Corporació Sanitària Parc Taulí
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Department of Surgery, Hospital Parc Taulí de Sabadell, Sabadell, Spain
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University Hospital Mútua de Terrassa · Corporació Sanitària Parc Taulí
Affiliation as printed
Department of Radiology, Hospital Parc Taulí de Sabadell, Sabadell, Spain
Department of Radiology, University Hospital Mútua Terassa, Terassa, Spain
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Centre Hospitalier Universitaire de Liège
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Department of Radiology, CHU de Liège, Liège, Belgium
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Agostino Gemelli University Polyclinic
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Department of Surgery, Gemelli University Hospital Rome, Rome, Italy
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Affiliation as printed
Department of Surgery, Amphia, Breda, The Netherlands
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Affiliation as printed
Department of Radiology, Hospital Clínic de Barcelona, Barcelona, Spain
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Wiener Krankenanstaltenverbund
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Department of Surgery, HPB Center Vienna Health Network, Clinic Favoriten, Vienna, Austria
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Affiliation as printed
Department of Surgery, Erasmus Medisch Centrum, Rotterdam, The Netherlands
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University Hospital Mútua de Terrassa
Affiliation as printed
Department of Radiology, University Hospital Mútua Terassa, Terassa, Spain
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University Medical Center Utrecht
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Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands
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Department of Surgery, University Hospital Frankfurt, Frankfurt, Germany
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Affiliation as printed
Department of General, Visceral and Transplant Surgery, University Hospital Aachen, Aachen, Germany
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Affiliation as printed
Department of Surgery, Clarunis University Hospital, Basel, Switzerland
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Affiliation as printed
Department of Radiology, St. Clara Spital, Basel, Switzerland
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Agostino Gemelli University Polyclinic
Affiliation as printed
Department of Radiology, Gemelli University Hospital, Rome, Italy
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Affiliation as printed
Department of Radiology, Amphia, Breda, The Netherlands
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Footscray Hospital · Western Health
Affiliation as printed
Department of Radiology, Western Health Footscray, Footscray, Australia
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Ospedale Maggiore Carlo Alberto Pizzardi
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Department of Surgery, Ospedale Maggiore di Bologna, Bologna, Italy
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Affiliation as printed
Department of Surgery, University Hospital Bonn, Bonn, Germany
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Amsterdam University Medical Centers · Vrije Universiteit Amsterdam · Amsterdam UMC Location Vrije Universiteit Amsterdam
Affiliation as printed
Department of Surgery, Amsterdam University Medical Centers Location VU, Amsterdam, The Netherlands
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Memorial Sloan Kettering Cancer Center
Affiliation as printed
Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, USA
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Department of Surgery, University Hospital Halle (Saale), Halle, Germany
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Department of Surgery, Clarunis University Hospital, Basel, Switzerland
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Department of Surgery, Maxima Medisch Centrum, Eindhoven, The Netherlands
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Department of Surgery, Hôpital Erasme, Brussels, Belgium
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Department of Radiology, Yale School of Medicine, New Haven, USA
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Department of Surgery, University Hospital Bonn, Bonn, Germany
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Department of Surgery, The Ottawa Hospital, Ottawa, Canada
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University Hospital Heidelberg
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Department of Surgery, University Hospital Heidelberg, Heidelberg, Germany
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Queen Elizabeth Hospital Birmingham
Affiliation as printed
Department of Radiology, Queen Elizabeth Hospital Birmingham NHS, Birmingham, UK
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Amsterdam University Medical Centers · Vrije Universiteit Amsterdam · Amsterdam UMC Location Vrije Universiteit Amsterdam
Affiliation as printed
Department of Radiology, Amsterdam University Medical Centers Location VU, Amsterdam, The Netherlands
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Affiliation as printed
Department of Surgery, King's College Hospital NHS, London, UK
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McGill University Health Centre
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Department of Surgery, McGill University Health Centre, Montréal, Canada
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Affiliation as printed
Department of Radiology and Nuclear Medicine, Erasmus Medisch Centrum, Rotterdam, The Netherlands
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University Hospital Southampton NHS Foundation Trust
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Department of Radiology, University Hospital Southampton NHS, Southampton, UK
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Ospedale Maggiore Carlo Alberto Pizzardi
Affiliation as printed
Department of Radiology, Ospedale Maggiore Di Bologna, Bologna, Italy
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Hospital Universitari Germans Trias i Pujol
Affiliation as printed
Department of Surgery, University Hospital Germans Trias I Pujol, Badalona, Spain
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Maastricht University Medical Centre · Maastricht University · Universitätsklinikum Aachen
Affiliation as printed
Department of General, Visceral and Transplant Surgery, University Hospital Aachen, Aachen, Germany
Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands
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Affiliation as printed
Department of Radiology, King's College Hospital NHS, London, UK
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University Hospital Southampton NHS Foundation Trust
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Department of Surgery, University Hospital Southampton NHS, Southampton, UK
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Fudan University · Zhongshan Hospital
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Department of Radiology, Zhongshan Hospital, Fundan University, Shanghai, China
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Affiliation as printed
Department of Surgery, Royal Free Hospital NHS, London, UK
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Affiliation as printed
Department of Surgery, Ospedale San Raffaele, Milan, Italy
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Memorial Sloan Kettering Cancer Center
Affiliation as printed
Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, USA
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Affiliation as printed
Department of Radiology, Royal Prince Alfred Hospital, Camperdown, Australia
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Affiliation as printed
Department of Surgery, University Hospital Halle (Saale), Halle, Germany
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Fondazione Poliambulanza Istituto Ospedaliero
Affiliation as printed
Department of Radiology, Fondazione Poliambulanza, Brescia, Italy
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Hospital Universitari Germans Trias i Pujol
Affiliation as printed
Department of Radiology, University Hospital Germans Trias I Pujol, Badalona, Spain
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Affiliation as printed
Department of Surgery, Biomedical and Clinical Sciences, Linköping University Hospital, Linköping, Sweden
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Hospital Universitario Miguel Servet
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Department of Radiology, University Hospital Miguel Servet, Saragossa, Spain
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Affiliation as printed
Department of Surgery, University Hospital Frankfurt, Frankfurt, Germany
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IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola
Affiliation as printed
Department of Surgery, General Surgery and Transplant Unit, IRCCS Azienda Ospedaliero- Universitaria di Bologna, Sant'Orsola-Malpighi Hospital, Bologna, Italy
Department of Surgery, General Surgery and Transplant Unit, IRCCS Azienda Ospedaliero- Universitaria di Bologna, Sant'Orsola-Malpighi Hospital, Bologna, Italy
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Hospital Universitario Miguel Servet
Affiliation as printed
Department of Surgery, University Hospital Miguel Servet, Saragossa, Spain
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