Stefano Partelli1, John K Ramage2, Sara Massironi3, Alessandro Zerbi4, Hong Beom Kim5, Patricia Niccoli6, Francesco Panzuto7, Luca Landoni8, Ales Tomazic9, Toni Ibrahim10, Gregory Kaltsas11, Emilio Bertani12, Alain Sauvanet13, Eva Segelov14, Martyn Caplin15, Jorgelina Coppa16, Thomas Armstrong17, Martin O Weickert18, Giovanni Butturini19, Stefan Staettner20, Florian Boesch21, Mauro Cives22, Carol Anne Moulton23,24, Jin He25, Andreas Selberherr26, Orit Twito27, Antonio Castaldi28, Claudio Giovanni De Angelis29, Sebastien Gaujoux30, Hussein Almeamar31, Andrea Frilling32, Emanuel Vigia33, Colin Wilson34, Francesca Muffatti1, Raj Srirajaskanthan2, Pietro Invernizzi3, Andrea Lania4, Wooil Kwon5, Jacques Ewald6, Maria Rinzivillo7, Chiara Nessi8, Lojze M Smid9, Andrea Gardini35, Marina Tsoli11, Edgardo E Picardi12, Olivia Hentic13, Daniel Croagh14, Christos Toumpanakis15, Davide Citterio16, Emma Ramsey17, Barbara Mosterman18, Paolo Regi19, Silvia Gasteiger36, Roberta E Rossi37, Valeria Smiroldo4, Jin-Young Jang5, Massimo Falconi1. 1. Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center, IRCCS San Raffaele Scientific Institute, Milan, Italy. 2. Kings Health Partners NET Center, Kings College Hospital London, London, United Kingdom. 3. Division of Gastroenterology, Centre for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy. 4. Humanitas Clinical and Research Center - IRCCS, Rozzano, Italy. 5. Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea. 6. Department of Medical Oncology, Paoli-Calmettes Institute, Marseille, France. 7. Digestive Disease Unit, ENETS Center of Excellence, Sant' Andrea University Hospital, Rome, Italy. 8. Department of Surgery, Pancreas Institute, Verona ENETS Center of Excellence, University and Hospital Trust of Verona, Verona, Italy. 9. Department of Abdominal Surgery and Gastroenterology and Hepatology, Faculty of Medicine, University Medical Centre Ljubljana, University of Ljubljana, Ljubljana, Slovenia. 10. Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy. 11. First Department of Propaedeutic and Internal Medicine, Laiko University Hospital, National and Kapodistrian University of Athens, Athens, Greece. 12. Division of Gastrointestinal Surgery, European Institute of Oncology, Milan, Italy. 13. Department 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. 14. Department of Oncology and Surgery (School of Clinical Sciences at Monash Health), Monash University, Clayton, VIC, Australia. 15. Centre for Gastroenterology, Neuroendocrine Tumour Unit, ENETS Centre of Excellence, Royal Free Hospital, London, United Kingdom. 16. Gastrointestinal 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. 17. Department of Hepatobiliary Surgery, Wessex NET Group ENETS Centre of Excellence, University Hospital Southampton, Southampton, United Kingdom. 18. The ARDEN NET Centre, European Neuroendocrine Tumour Society (ENETS) Centre of Excellence (CoE), University Hospitals Coventry and Warwickshire NHS Trust, Coventry, United Kingdom. 19. Department of Surgery, Pederzoli Hospital, Peschiera del Garda, Italy. 20. Department of General, Visceral and Vascular Surgery, Salzkammergutklinikum Vöcklabruck, Vöcklabruck, Austria. 21. Department of General, Visceral and Transplantation Surgery, University Hospital, LMU Munich, Munich, Germany. 22. Section of Medical Oncology, Department of Biomedical Sciences and Clinical Oncology (DIMO), University of Bari 'Aldo Moro', Bari, Italy. 23. Division of General Surgery, University of Toronto, Toronto, ON, Canada. 24. Department of Surgery, University Health Network, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada. 25. Department of Surgery, The Sol Goldman Pancreatic Cancer Research Center, Johns Hopkins Medical Institutions, Baltimore, MA, United States. 26. Section Endocrine Surgery, Division of General Surgery, Department of Surgery, Medical University, Vienna, Austria. 27. Sackler Faculty of Medicine, Endocrine Institute, Meir Medical Center, Tel-Aviv University, Tel-Aviv, Israel. 28. Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy. 29. Gastroenterology Unit, Department of Medical Sciences, City of Health and Science Hospital, Turin, Italy. 30. Department of Digestive, Hepatobiliary and Endocrine Surgery, Paris Descartes University, Cochin Hospital, Paris, France. 31. National NET Centre and ENETS Centre of Excellence, St Vincent's University Hospital, Dublin, Ireland. 32. Department of Surgery and Cancer, Imperial College London, London, United Kingdom. 33. Centro Hepatobiliopancreático, Hospital Curry Cabral, Nova Univerditu of Lisbon, Lisbon, Portugal. 34. HPB Surgical Unit, Newcastle upon Tyne Teaching Hospitals Foundation Trust, Newcastle upon Tyne, United Kingdom. 35. General and Oncologic Surgery Unit, Morgagni-Pierantoni Hospital, Forlì, Italy. 36. Department of Visceral, Transplantation and Thoracic Surgery, Medical University of Innsbruck, Innsbruck, Austria. 37. Department of Pathophysiology and Transplantation, University of Milan, Milano, Italy.
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.
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.
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