Asymptomatic Small Pancreatic Endocrine Neoplasms (ASPEN Study)
Research type
Research Study
Full title
A Prospective Evaluation of the Management of Sporadic Asymptomatic Nonfunctioning Pancreatic Neuroendocrine Neoplasms ≤ 2 cm
IRAS ID
231944
Contact name
John Ramage
Contact email
Sponsor organisation
Hampshire Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
NCT03084770, www.clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
The study is designed as a prospective international (including also non-European institutions) multicentre cohort study, which will be coordinated by the Pancreatic Surgery Unit of San Raffaele Scientific Institute (Lead Study Centre) under the auspices of the European Neuroendocrine Tumor Society (ENETS).
The study duration is 6 years, patients will be recruited for 5 years from December 2016 to December 2021, with a follow up of 1 year at least (end of the study: December 2022). After 2 years of recruitment an interim analysis will be performed in December 2018. San Raffaele Scientific Institute will be the lead centre from where the international study will be managed and coordinated. Participating study centres will identify, recruit patients and will send pseudoanonimised data of patients to the lead centre, which is responsible for statistical analysis, storing and controlling data. The research database will be managed and analysed by the Lead Study centre research team. Study participation is voluntary, there will be no reimbursement for patients.Summary of study results:
The results of the ASPEN study show that small asymptomatic neureondocrine tumours of the pancreas can be managed by observation alone. If the tumour is less than 2 cm in diameter, the risks of operating on these tumours is greater than the risks of spread of the tumour. There are however, some features on scans that will suggest an operation to remove the tumour may be needed, but these features are uncommon. This study has increased our understanding of these tumours. Further information may be available after further analysis in the future.
REC name
East of England - Essex Research Ethics Committee
REC reference
17/EE/0493
Date of REC Opinion
24 Jan 2018
REC opinion
Further Information Favourable Opinion