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

Published on Dec 23, 2020in Frontiers of Medicine in China
· DOI :10.3389/FMED.2020.598438
Stefano Partelli1
Estimated H-index: 1
Stefano Partelli1
Estimated H-index: 1
+ 54 AuthorsMassimo Falconi105
Estimated H-index: 105
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 less than 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 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.
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#2Nipun B. Merchant (UM: University of Miami)H-Index: 50
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#1Ashley K. Clift (University of Oxford)H-Index: 13
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Abstract Surgery represents a fundamental component of treatment strategies in neuroendocrine neoplasms. Resection of the primary tumour as well as loco-regional and distant deposits is currently the only modality possessing chance of cure from neuroendocrine neoplasia disease. However, surgical intervention may also have legitimate palliative intents, such as cytoreduction of hormonally active tumour bulk that is not responsive to medical therapy and/or causes local symptoms. In some scenarios,...
Abstract Pancreatic neuroendocrine neoplasms (pNENs) are relatively rare tumors that have been increasingly recognized in recent years. They are highly heterogeneous and exhibit a diverse clinical course, along with a variable metastatic propensity related to their molecular biology profile, grade, extent of disease and functional status. PNENs are divided into functioning and non-functioning tumor forms. Their pathological classification is based mainly on their histology and proliferative acti...
#1Kate Mowrey (University of Texas Health Science Center at Houston)
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