AUTHOR=Partelli Stefano , Ramage John K. , Massironi Sara , Zerbi Alessandro , Kim Hong Beom , Niccoli Patricia , Panzuto Francesco , Landoni Luca , Tomazic Ales , Ibrahim Toni , Kaltsas Gregory , Bertani Emilio , Sauvanet Alain , Segelov Eva , Caplin Martyn , Coppa Jorgelina , Armstrong Thomas , Weickert Martin O. , Butturini Giovanni , Staettner Stefan , Boesch Florian , Cives Mauro , Moulton Carol Anne , He Jin , Selberherr Andreas , Twito Orit , Castaldi Antonio , De Angelis Claudio Giovanni , Gaujoux Sebastien , Almeamar Hussein , Frilling Andrea , Vigia Emanuel , Wilson Colin , Muffatti Francesca , Srirajaskanthan Raj , Invernizzi Pietro , Lania Andrea , Kwon Wooil , Ewald Jacques , Rinzivillo Maria , Nessi Chiara , Smid Lojze M. , Gardini Andrea , Tsoli Marina , Picardi Edgardo E. , Hentic Olivia , Croagh Daniel , Toumpanakis Christos , Citterio Davide , Ramsey Emma , Mosterman Barbara , Regi Paolo , Gasteiger Silvia , Rossi Roberta E. , Smiroldo Valeria , Jang Jin-Young , Falconi Massimo 

TITLE=Management of Asymptomatic Sporadic Nonfunctioning Pancreatic Neuroendocrine Neoplasms (ASPEN) ≤2 cm: Study Protocol for a Prospective Observational Study

JOURNAL=Frontiers in Medicine

VOLUME=7

YEAR=2020

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2020.598438

DOI=10.3389/fmed.2020.598438

ISSN=2296-858X

ABSTRACT=<p><bold>Introduction:</bold> 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 &lt;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.</p><p><bold>Methods:</bold> ASPEN is a prospective international observational multicentric cohort study supported by ENETS. The study is registered in <ext-link ext-link-type="uri" xlink:href="https://ClinicalTrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">ClinicalTrials.gov</ext-link> 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 &gt;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 <sup>68</sup>Gallium DOTATOC-PET scan.</p><p><bold>Conclusion:</bold> The ASPEN study is designed to investigate if an active surveillance of asymptomatic NF-PanNEN ≤2 cm is safe as compared to surgical approach.</p>