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 StaettnerFlorian Boesch, Mauro Cives, 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

Research output: Contribution to journalArticlepeer-review

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 textless2 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 textgreater18 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 (68)Gallium 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.
Original languageEnglish
Pages (from-to)598438
Number of pages1
JournalFrontiers in Medicine
Volume7
DOIs
Publication statusPublished - 2020

Keywords

  • management
  • surgery
  • follow-up
  • ASPEN study
  • NF-PanNEN2 cm
  • small nonfunctioning pancreatic neuroendocrine neoplasm
  • surveillance

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