16 research outputs found

    Management of asymptomatic sporadic non-functioning pancreatic neuroendocrine neoplasms no larger than 2 cm. interim analysis of prospective ASPEN trial

    Get PDF
    The incidence of non-functioning pancreatic neuroendocrine neoplasms (NF-PanNENs) has increased recently. Traditionally, surgery has been the treatment of choice for localized NF-PanNENs, although evidence has emerged that active surveillance could be advocated for most asymptomatic tumours no larger than 2 cm. However, the practice of active surveillance varies considerably and, contrary to current recommendations, many patients still undergo surgical resection. Current evidence is limited by the retrospective design of studies and the small number of patients. The present study is the most extensive prospective investigation to date on small, asymptomatic NF-PanNENs. The aim was to define the optimal management of incidentally found, sporadic NF-PanNENs no larger than 2 cm

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

    Get PDF
    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 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.info:eu-repo/semantics/publishedVersio

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

    No full text
    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

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

    No full text
    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

    Preoperative von willebrand factor – antigen predicts clinical outcome after liver resection: a prospective, international, multicenter trial

    No full text
    Backgroundand Aims:vWF-antigenhasbeenshowntobeincreased in patients with portal hypertension and to predict mortality in patients with chronic liver disease. This study aimed to assess the clinical utility of preoperative vWF-antigen levels to predict poor postoperative outcome in patients undergoing liver resection in a routine clinical setting. Methods: 95patientsundergoingliverresectionservedasprospective exploration cohort and results were validated in an independent cohort of 133 patients for 4 different institutions. VWF-Ag was evaluated perioperativelyand postoperative outcomewas recorded. Results: Preoperative vWF-antigen levels significantly predicted postoperative liver dysfunction (LD, area under the curve [AUC]: 0.725, P=0.009). Furthermore, a cut-off of vWF-antigen ≥182% was defined to identify patients with a higher incidence of postoperative LDormorbidity(LD:≥182%:33.3%,<182%:5.9%,P<0.001;morbidity: ≥182%: 74.1%, <182%: 44.1%, P=0.008). We confirmed our results within a prospective validation cohort (LD: ≥182%: 20.0%, <182%: 5.2%, P=0.008; morbidity: ≥182%: 56.4%, <182%: 35.1%, P=0.015). Analyzing the entire cohort, we found that patients exceeding the cut-off suffered from a significantly increased incidence of postoperative LD, morbidity, prolonged hospitalization, intensive care unit stayand mortality. Conclusions: Within this study we were able to reveal and subsequently validate the potential of preoperative vWF-antigen levels to predict poor postoperative outcome in patients undergoing liver resection. As vWF-antigen is easily determined and available in most standard laboratories, it seems to be avaluable clinical marker to allow for preoperative risk-stratification of patients undergoing liver resection
    corecore