Τίτλος:
Management of Asymptomatic Sporadic Nonfunctioning Pancreatic Neuroendocrine Neoplasms (ASPEN) ≤2 cm: Study Protocol for a Prospective Observational Study
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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. © 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.
Συγγραφείς:
Partelli, S.
Ramage, J.K.
Massironi, S.
Zerbi, A.
Kim, H.B.
Niccoli, P.
Panzuto, F.
Landoni, L.
Tomazic, A.
Ibrahim, T.
Kaltsas, G.
Bertani, E.
Sauvanet, A.
Segelov, E.
Caplin, M.
Coppa, J.
Armstrong, T.
Weickert, M.O.
Butturini, G.
Staettner, S.
Boesch, F.
Cives, M.
Moulton, C.A.
He, J.
Selberherr, A.
Twito, O.
Castaldi, A.
De Angelis, C.G.
Gaujoux, S.
Almeamar, H.
Frilling, A.
Vigia, E.
Wilson, C.
Muffatti, F.
Srirajaskanthan, R.
Invernizzi, P.
Lania, A.
Kwon, W.
Ewald, J.
Rinzivillo, M.
Nessi, C.
Smid, L.M.
Gardini, A.
Tsoli, M.
Picardi, E.E.
Hentic, O.
Croagh, D.
Toumpanakis, C.
Citterio, D.
Ramsey, E.
Mosterman, B.
Regi, P.
Gasteiger, S.
Rossi, R.E.
Smiroldo, V.
Jang, J.-Y.
Falconi, M.
Περιοδικό:
Frontiers in Cardiovascular Medicine
Εκδότης:
Frontiers Media S.A
Λέξεις-κλειδιά:
edotreotide ga 68, active surveillance; adult; Article; asymptomatic sporadic nonfunctioning pancreatic neuroendocrine neoplasm; cancer diagnosis; cancer growth; cancer incidence; cancer patient; cancer recurrence; cancer surgery; cancer survival; clinical trial protocol; cohort analysis; computer assisted tomography; disease free survival; fine needle aspiration biopsy; human; major clinical study; multicenter study; nuclear magnetic resonance imaging; observational study; pancreas islet cell tumor; positron emission tomography; progression free survival; prospective study
DOI:
10.3389/fmed.2020.598438
