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
Sources
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 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 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.
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AbstractThis manuscript is the result of the North American Neuroendocrine Tumor Society consensus conference on the surgical management of pancreatic neuroendocrine tumors from July 19 to 20, 2018. The group reviewed a series of questions of specific interest to surgeons taking care of patients wit
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9 CitationsSource
#1Stefano PartelliH-Index: 43
#2Michele MazzaH-Index: 4
Last. Massimo FalconiH-Index: 105
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Abstract Background International guidelines suggest a watchful strategy for small nonfunctioning pancreatic neuroendocrine tumors. The aim of this study was to evaluate the management and indications for surgery in patients with asymptomatic nonfunctioning pancreatic neuroendocrine tumors ≤2 cm. Methods Patients with asymptomatic, incidental, sporadic nonfunctioning pancreatic neuroendocrine tumors ≤2 cm without nodal or distant metastases were included (2012–2016). A comparison between active ...
19 CitationsSource
#1Stefano PartelliH-Index: 43
#2Fabio GiannoneH-Index: 2
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BACKGROUND/AIMS: The annual incidence of pancreatic neuroendocrine tumors (PanNET) has been estimated to be around 0.8/100,000 inhabitants. The aim of this study was to determine the frequency of incidental histological diagnosis of PanNET in pancreatic specimen evaluation for a purpose other other than PanNET diagnosis. METHODS: One thousand seventy-four histopathological examinations of pancreatic specimens performed in 3 centers in Italy were retrospectively reviewed. All cases with a main pa...
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Background ENETS guidelines recommend parenchyma-sparing procedures without formal lymphadenectomy, ideally with a minimally invasive laparoscopic approach for sporadic small pNENs (≤2 cm). Non-functioning (NF) small pNENs can also be observed. The aim of the study was to evaluate how these recommendations are implemented in the German surgical community.
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Abstract Background Non-functional pancreatic neuroendocrine tumors (NF-PNET) are rare neoplasms being increasingly diagnosed. Surgical treatment or expectant management are both suggested for small NF-PNETs. The aim of this study was to evaluate the outcome of surveillance strategy for small NF-PNETs. Methods A systematic search was performed up to March 2016 in MEDLINE, EMBASE and the Cochrane Library according to the PRISMA guidelines. Data was pooled using the random-effects model. Results N...
46 CitationsSource
#1Stefano PartelliH-Index: 43
#2Roberto CirocchiH-Index: 43
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Background The incidence of asymptomatic, sporadic, small non-functioning pancreatic neuroendocrine neoplasms (NF-PNENs) has increased in recent decades. Conservative treatment has been advocated for these tumours. The aim of this study was systematically to evaluate the literature on active surveillance and to compare this with surgical management for asymptomatic sporadic small NF-PNENs. Methods PubMed, Embase and the Cochrane Library were searched systematically for studies that compared the ...
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Objective To analyze the natural history of small asymptomatic pancreatic neuroendocrine tumors (PanNET) and to present a matched comparison between groups who underwent either initial observation or resection. Management approach for small PanNET is uncertain.
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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,...
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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...
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#1Kate Mowrey (University of Texas Health Science Center at Houston)
#2Hope Northrup (University of Texas Health Science Center at Houston)H-Index: 46
Last. David Rodriguez-Buritica (University of Texas Health Science Center at Houston)H-Index: 7
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Background: Tuberous sclerosis complex (TSC) is a genetic condition that causes benign tumors to grow in multiple organ systems. Nonfunctional pancreatic neuroendocrine tumors (PNETs) are a rare clinical feature of TSC with no specific guidelines outlined for clinical management at this time. Our purpose is to calculate the prevalence of nonfunctional PNETs as well as characterize the presentation, current clinical management, and assess the impact of systemic mammalian target of rapamycin (mTOR...
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