NCT03084770

Asymptomatic Small Pancreatic Endocrine Neoplasms.

A Prospective Evaluation of the Management of Sporadic Asymptomatic Nonfunctioning Pancreatic Neuroendocrine Neoplasms ≤ 2 cm

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the most appropriate management of sporadic asymptomatic non-functioning pancreatic neuroendocrine neoplasms (NF-PNEN) ≤ 2 cm. P NF-PNEN management will be decided at the hospital and all therapeutics decision will be decided/coordinated by the treating physician. Patients will be either submitted to surgical resection or to active surveillance.

Detailed description

In the last decade a dramatic increase in diagnosis of small, incidentally discovered, NF-PNEN was observed. Various study indicates the safety of a conservative management for this lesion and the The European Neuroendocrine Tumor Society (ENETS) proposed a "wait and see" approach for small NF-PNEN. Indications for surgery include the presence of a localized NF-PNEN in the absence of distant metastases as curative resection of these tumors is associated with favourable prognosis especially for low grade. In the last decade a dramatic increase in diagnosis of small, incidentally discovered, NF-PNEN was observed.Moreover, other investigators observed a clear relationship between the tumor diameter and low risk of malignancy and systemic progression. In particular, a tumor size ≤ 2 cm seems to be associated with a negligible risk of disease recurrence and with a very low incidence of aggressive features such as lymph node involvement.On this basis, the European Neuroendocrine Tumor Society (ENETS) proposed a "wait and see" approach for small NF-PNEN when incidentally discovered. Since then, various series evaluated the safety of a conservative management for small, sporadic, incidentally diagnosed, NF-PNEN. After a median follow-up of 28-45 months, all the studies confirmed that an intensive surveillance for incidental and small NF-PNEN is safe in selected cases. Nevertheless, available data are based only on retrospective series with a significant heterogeneity of inclusion criteria and different tumor diameter cut-off and the appropriate management of this entities (surveillance versus surgery) is still a matter of debate.

Conditions

• Non Functioning Pancreatic Endocrine Tumor

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Radiological imaging studies	Patients will be submitted to radiological imaging studies (CT scan and/or MRI and/ or 68Gallium PET/CT and/or Octreoscan and/or EUS+FNAand/or Octreoscan and/or EUS+FNA) at diagnosis, and then every 6 months for the first two years and yearly thereafter for five years in the absence of significant changes on imaging or symptoms appearance. Every 12 months (or 6 months for patients with Ki67\> 2%) a high quality imaging (CT scan or MRI) is required.
OTHER	Quality of Life Assessment	quality of life and the perceived burden of surveillance or follow-up after surgery for participants, will be investigated by administrating HADS questionnaire and EORTC QLQ-C30 (version 3) and EORTC QLQ-GI.NET21 Module.

Timeline

• Start date: 2017-09-01
• Primary completion: 2024-08-31
• Completion: 2024-12-31
• First posted: 2017-03-21
• Last updated: 2024-01-18

Locations

1 site across 1 country: Italy