TY - JOUR
T1 - Management of Asymptomatic Sporadic Nonfunctioning Pancreatic Neuroendocrine Neoplasms (ASPEN) ≤2 cm
T2 - Study Protocol for a Prospective Observational Study
AU - Partelli, Stefano
AU - Ramage, John K
AU - Massironi, Sara
AU - Zerbi, Alessandro
AU - Kim, Hong Beom
AU - Niccoli, Patricia
AU - Panzuto, Francesco
AU - Landoni, Luca
AU - Tomazic, Ales
AU - Ibrahim, Toni
AU - Kaltsas, Gregory
AU - Bertani, Emilio
AU - Sauvanet, Alain
AU - Segelov, Eva
AU - Caplin, Martyn
AU - Coppa, Jorgelina
AU - Armstrong, Thomas
AU - Weickert, Martin O
AU - Butturini, Giovanni
AU - Staettner, Stefan
AU - Boesch, Florian
AU - Cives, Mauro
AU - Moulton, Carol Anne
AU - He, Jin
AU - Selberherr, Andreas
AU - Twito, Orit
AU - Castaldi, Antonio
AU - De Angelis, Claudio Giovanni
AU - Gaujoux, Sebastien
AU - Almeamar, Hussein
AU - Frilling, Andrea
AU - Vigia, Emanuel
AU - Wilson, Colin
AU - Muffatti, Francesca
AU - Srirajaskanthan, Raj
AU - Invernizzi, Pietro
AU - Lania, Andrea
AU - Kwon, Wooil
AU - Ewald, Jacques
AU - Rinzivillo, Maria
AU - Nessi, Chiara
AU - Smid, Lojze M
AU - Gardini, Andrea
AU - Tsoli, Marina
AU - Picardi, Edgardo E
AU - Hentic, Olivia
AU - Croagh, Daniel
AU - Toumpanakis, Christos
AU - Citterio, Davide
AU - Ramsey, Emma
AU - Mosterman, Barbara
AU - Regi, Paolo
AU - Gasteiger, Silvia
AU - Rossi, Roberta E
AU - Smiroldo, Valeria
AU - Jang, Jin-Young
AU - Falconi, Massimo
N1 - Copyright © 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.
PY - 2020
Y1 - 2020
N2 - 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.
AB - 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.
U2 - 10.3389/fmed.2020.598438
DO - 10.3389/fmed.2020.598438
M3 - Article
C2 - 33425946
VL - 7
SP - 598438
JO - Frontiers in Medicine
JF - Frontiers in Medicine
SN - 2296-858X
ER -