@article{0888e4b74f9748dcb5a0afcb7a328924,
title = "Management of Asymptomatic Sporadic Nonfunctioning Pancreatic Neuroendocrine Neoplasms (ASPEN) ≤2 cm: Study Protocol for a Prospective Observational Study",
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 = "ASPEN study, NF-PanNEN_2 cm, follow-up, management, small nonfunctioning pancreatic neuroendocrine neoplasm, surgery, surveillance",
author = "Stefano Partelli and Ramage, {John K.} and Sara Massironi and Alessandro Zerbi and Kim, {Hong Beom} and Patricia Niccoli and Francesco Panzuto and Luca Landoni and Ales Tomazic and Toni Ibrahim and Gregory Kaltsas and Emilio Bertani and Alain Sauvanet and Eva Segelov and Martyn Caplin and Jorgelina Coppa and Thomas Armstrong and Weickert, {Martin O.} and Giovanni Butturini and Stefan Staettner and Florian Boesch and Mauro Cives and Moulton, {Carol Anne} and Jin He and Andreas Selberherr and Orit Twito and Antonio Castaldi and {De Angelis}, {Claudio Giovanni} and Sebastien Gaujoux and Hussein Almeamar and Andrea Frilling and Emanuel Vigia and Colin Wilson and Francesca Muffatti and Raj Srirajaskanthan and Pietro Invernizzi and Andrea Lania and Wooil Kwon and Jacques Ewald and Maria Rinzivillo and Chiara Nessi and Smid, {Lojze M.} and Andrea Gardini and Marina Tsoli and Picardi, {Edgardo E.} and Olivia Hentic and Daniel Croagh and Christos Toumpanakis and Davide Citterio and Emma Ramsey and Barbara Mosterman and Paolo Regi and Silvia Gasteiger and Rossi, {Roberta E.} and Valeria Smiroldo and Jang, {Jin Young} and Massimo Falconi",
note = "Funding Information: Funding. The European Neuroendocrine Tumor Society (ENETS) financially supported the ASPEN study. Publisher Copyright: {\textcopyright} Copyright {\textcopyright} 2020 Partelli, Ramage, Massironi, Zerbi, Kim, Niccoli, Panzuto, Landoni, Tomazic, Ibrahim, Kaltsas, Bertani, Sauvanet, Segelov, Caplin, Coppa, Armstrong, Weickert, Butturini, Staettner, Boesch, Cives, Moulton, He, Selberherr, Twito, Castaldi, De Angelis, Gaujoux, Almeamar, Frilling, Vigia, Wilson, Muffatti, Srirajaskanthan, Invernizzi, Lania, Kwon, Ewald, Rinzivillo, Nessi, Smid, Gardini, Tsoli, Picardi, Hentic, Croagh, Toumpanakis, Citterio, Ramsey, Mosterman, Regi, Gasteiger, Rossi, Smiroldo, Jang and Falconi.",
year = "2020",
month = dec,
day = "23",
doi = "10.3389/fmed.2020.598438",
language = "English (US)",
volume = "7",
journal = "Frontiers in Medicine",
issn = "2296-858X",
publisher = "Frontiers Media S. A.",
}