Frontiers in Medicine (Dec 2020)
Management of Asymptomatic Sporadic Nonfunctioning Pancreatic Neuroendocrine Neoplasms (ASPEN) ≤2 cm: Study Protocol for a Prospective Observational Study
- Stefano Partelli,
- John K. Ramage,
- Sara Massironi,
- Alessandro Zerbi,
- Hong Beom Kim,
- Patricia Niccoli,
- Francesco Panzuto,
- Luca Landoni,
- Ales Tomazic,
- Toni Ibrahim,
- Gregory Kaltsas,
- Emilio Bertani,
- Alain Sauvanet,
- Eva Segelov,
- Martyn Caplin,
- Jorgelina Coppa,
- Thomas Armstrong,
- Martin O. Weickert,
- Giovanni Butturini,
- Stefan Staettner,
- Florian Boesch,
- Mauro Cives,
- Carol Anne Moulton,
- Carol Anne Moulton,
- Jin He,
- Andreas Selberherr,
- Orit Twito,
- Antonio Castaldi,
- Claudio Giovanni De Angelis,
- Sebastien Gaujoux,
- Hussein Almeamar,
- Andrea Frilling,
- Emanuel Vigia,
- Colin Wilson,
- Francesca Muffatti,
- Raj Srirajaskanthan,
- Pietro Invernizzi,
- Andrea Lania,
- Wooil Kwon,
- Jacques Ewald,
- Maria Rinzivillo,
- Chiara Nessi,
- Lojze M. Smid,
- Andrea Gardini,
- Marina Tsoli,
- Edgardo E. Picardi,
- Olivia Hentic,
- Daniel Croagh,
- Christos Toumpanakis,
- Davide Citterio,
- Emma Ramsey,
- Barbara Mosterman,
- Paolo Regi,
- Silvia Gasteiger,
- Roberta E. Rossi,
- Valeria Smiroldo,
- Jin-Young Jang,
- Massimo Falconi
Affiliations
- Stefano Partelli
- Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center, IRCCS San Raffaele Scientific Institute, Milan, Italy
- John K. Ramage
- Kings Health Partners NET Center, Kings College Hospital London, London, United Kingdom
- Sara Massironi
- Division of Gastroenterology, Centre for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy
- Alessandro Zerbi
- Humanitas Clinical and Research Center – IRCCS, Rozzano, Italy
- Hong Beom Kim
- Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea
- Patricia Niccoli
- Department of Medical Oncology, Paoli-Calmettes Institute, Marseille, France
- Francesco Panzuto
- Digestive Disease Unit, ENETS Center of Excellence, Sant' Andrea University Hospital, Rome, Italy
- Luca Landoni
- Department of Surgery, Pancreas Institute, Verona ENETS Center of Excellence, University and Hospital Trust of Verona, Verona, Italy
- Ales Tomazic
- Department of Abdominal Surgery and Gastroenterology and Hepatology, Faculty of Medicine, University Medical Centre Ljubljana, University of Ljubljana, Ljubljana, Slovenia
- Toni Ibrahim
- 0Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy
- Gregory Kaltsas
- 1First Department of Propaedeutic and Internal Medicine, Laiko University Hospital, National and Kapodistrian University of Athens, Athens, Greece
- Emilio Bertani
- 2Division of Gastrointestinal Surgery, European Institute of Oncology, Milan, Italy
- Alain Sauvanet
- 3Department of HPB Surgery and Liver Transplantation and Pancreatology, Beaujon Hospital, University Paris 7 Denis Diderot, Assistance publique-Hôpitaux de Paris, 100, Boulevard du Général-Leclerc, Clichy, France
- Eva Segelov
- 4Department of Oncology and Surgery (School of Clinical Sciences at Monash Health), Monash University, Clayton, VIC, Australia
- Martyn Caplin
- 5Centre for Gastroenterology, Neuroendocrine Tumour Unit, ENETS Centre of Excellence, Royal Free Hospital, London, United Kingdom
- Jorgelina Coppa
- 6Gastrointestinal and Hepato-Pancreatic Surgery and Liver Transplantation Unit, Fondazione, IRCCS Istituto Nazionale Tumori (INT, National Cancer Institute) and Università degli Studi di Milano, Milan, Italy
- Thomas Armstrong
- 7Department of Hepatobiliary Surgery, Wessex NET Group ENETS Centre of Excellence, University Hospital Southampton, Southampton, United Kingdom
- Martin O. Weickert
- 8The ARDEN NET Centre, European Neuroendocrine Tumour Society (ENETS) Centre of Excellence (CoE), University Hospitals Coventry and Warwickshire NHS Trust, Coventry, United Kingdom
- Giovanni Butturini
- 9Department of Surgery, Pederzoli Hospital, Peschiera del Garda, Italy
- Stefan Staettner
- 0Department of General, Visceral and Vascular Surgery, Salzkammergutklinikum Vöcklabruck, Vöcklabruck, Austria
- Florian Boesch
- 1Department of General, Visceral and Transplantation Surgery, University Hospital, LMU Munich, Munich, Germany
- Mauro Cives
- 2Section of Medical Oncology, Department of Biomedical Sciences and Clinical Oncology (DIMO), University of Bari 'Aldo Moro', Bari, Italy
- Carol Anne Moulton
- 3Division of General Surgery, University of Toronto, Toronto, ON, Canada
- Carol Anne Moulton
- 4Department of Surgery, University Health Network, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada
- Jin He
- 5Department of Surgery, The Sol Goldman Pancreatic Cancer Research Center, Johns Hopkins Medical Institutions, Baltimore, MA, United States
- Andreas Selberherr
- 6Section Endocrine Surgery, Division of General Surgery, Department of Surgery, Medical University, Vienna, Austria
- Orit Twito
- 7Sackler Faculty of Medicine, Endocrine Institute, Meir Medical Center, Tel-Aviv University, Tel-Aviv, Israel
- Antonio Castaldi
- 8Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy
- Claudio Giovanni De Angelis
- 9Gastroenterology Unit, Department of Medical Sciences, City of Health and Science Hospital, Turin, Italy
- Sebastien Gaujoux
- 0Department of Digestive, Hepatobiliary and Endocrine Surgery, Paris Descartes University, Cochin Hospital, Paris, France
- Hussein Almeamar
- 1National NET Centre and ENETS Centre of Excellence, St Vincent's University Hospital, Dublin, Ireland
- Andrea Frilling
- 2Department of Surgery and Cancer, Imperial College London, London, United Kingdom
- Emanuel Vigia
- 3Centro Hepatobiliopancreático, Hospital Curry Cabral, Nova Univerditu of Lisbon, Lisbon, Portugal
- Colin Wilson
- 4HPB Surgical Unit, Newcastle upon Tyne Teaching Hospitals Foundation Trust, Newcastle upon Tyne, United Kingdom
- Francesca Muffatti
- Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center, IRCCS San Raffaele Scientific Institute, Milan, Italy
- Raj Srirajaskanthan
- Kings Health Partners NET Center, Kings College Hospital London, London, United Kingdom
- Pietro Invernizzi
- Division of Gastroenterology, Centre for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy
- Andrea Lania
- Humanitas Clinical and Research Center – IRCCS, Rozzano, Italy
- Wooil Kwon
- Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea
- Jacques Ewald
- Department of Medical Oncology, Paoli-Calmettes Institute, Marseille, France
- Maria Rinzivillo
- Digestive Disease Unit, ENETS Center of Excellence, Sant' Andrea University Hospital, Rome, Italy
- Chiara Nessi
- Department of Surgery, Pancreas Institute, Verona ENETS Center of Excellence, University and Hospital Trust of Verona, Verona, Italy
- Lojze M. Smid
- Department of Abdominal Surgery and Gastroenterology and Hepatology, Faculty of Medicine, University Medical Centre Ljubljana, University of Ljubljana, Ljubljana, Slovenia
- Andrea Gardini
- 5General and Oncologic Surgery Unit, Morgagni-Pierantoni Hospital, Forlì, Italy
- Marina Tsoli
- 1First Department of Propaedeutic and Internal Medicine, Laiko University Hospital, National and Kapodistrian University of Athens, Athens, Greece
- Edgardo E. Picardi
- 2Division of Gastrointestinal Surgery, European Institute of Oncology, Milan, Italy
- Olivia Hentic
- 3Department of HPB Surgery and Liver Transplantation and Pancreatology, Beaujon Hospital, University Paris 7 Denis Diderot, Assistance publique-Hôpitaux de Paris, 100, Boulevard du Général-Leclerc, Clichy, France
- Daniel Croagh
- 4Department of Oncology and Surgery (School of Clinical Sciences at Monash Health), Monash University, Clayton, VIC, Australia
- Christos Toumpanakis
- 5Centre for Gastroenterology, Neuroendocrine Tumour Unit, ENETS Centre of Excellence, Royal Free Hospital, London, United Kingdom
- Davide Citterio
- 6Gastrointestinal and Hepato-Pancreatic Surgery and Liver Transplantation Unit, Fondazione, IRCCS Istituto Nazionale Tumori (INT, National Cancer Institute) and Università degli Studi di Milano, Milan, Italy
- Emma Ramsey
- 7Department of Hepatobiliary Surgery, Wessex NET Group ENETS Centre of Excellence, University Hospital Southampton, Southampton, United Kingdom
- Barbara Mosterman
- 8The ARDEN NET Centre, European Neuroendocrine Tumour Society (ENETS) Centre of Excellence (CoE), University Hospitals Coventry and Warwickshire NHS Trust, Coventry, United Kingdom
- Paolo Regi
- 9Department of Surgery, Pederzoli Hospital, Peschiera del Garda, Italy
- Silvia Gasteiger
- 6Department of Visceral, Transplantation and Thoracic Surgery, Medical University of Innsbruck, Innsbruck, Austria
- Roberta E. Rossi
- 7Department of Pathophysiology and Transplantation, University of Milan, Milano, Italy
- Valeria Smiroldo
- Humanitas Clinical and Research Center – IRCCS, Rozzano, Italy
- Jin-Young Jang
- Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea
- Massimo Falconi
- Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center, IRCCS San Raffaele Scientific Institute, Milan, Italy
- DOI
- https://doi.org/10.3389/fmed.2020.598438
- Journal volume & issue
-
Vol. 7
Abstract
Introduction: The optimal treatment for small, asymptomatic, nonfunctioning pancreatic neuroendocrine neoplasms (NF-PanNEN) is still controversial. European Neuroendocrine Tumor Society (ENETS) guidelines recommend a watchful strategy for asymptomatic NF-PanNEN <2 cm of diameter. Several retrospective series demonstrated that a non-operative management is safe and feasible, but no prospective studies are available. Aim of the ASPEN study is to evaluate the optimal management of asymptomatic NF-PanNEN ≤2 cm comparing active surveillance and surgery.Methods: ASPEN is a prospective international observational multicentric cohort study supported by ENETS. The study is registered in ClinicalTrials.gov with the identification code NCT03084770. Based on the incidence of NF-PanNEN the number of expected patients to be enrolled in the ASPEN study is 1,000 during the study period (2017–2022). Primary endpoint is disease/progression-free survival, defined as the time from study enrolment to the first evidence of progression (active surveillance group) or recurrence of disease (surgery group) or death from disease. Inclusion criteria are: age >18 years, the presence of asymptomatic sporadic NF-PanNEN ≤2 cm proven by a positive fine-needle aspiration (FNA) or by the presence of a measurable nodule on high-quality imaging techniques that is positive at 68Gallium DOTATOC-PET scan.Conclusion: The ASPEN study is designed to investigate if an active surveillance of asymptomatic NF-PanNEN ≤2 cm is safe as compared to surgical approach.
Keywords
- small nonfunctioning pancreatic neuroendocrine neoplasm
- NF-PanNEN_2 cm
- management
- surgery
- surveillance
- follow-up
