Non Functioning Pancreatic Endocrine Tumor
Conditions
Keywords
NF-PNEN
Brief 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.
Interventions
DIAGNOSTIC_TESTRadiological 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.
OTHERQuality 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.
Sponsors
IRCCS San Raffaele
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Individuals with asymptomatic sporadic NF-PNEN ≤ 2 cm * Diagnosis has to be proven by a positive fine-needle aspiration (FNA) or by the presence of a measurable nodule on high-quality imaging technique (CT or MR) that is positive at 68Gallium DOTATOC-PET scan or Octreoscan. * Patients who undergo surgery for NF-PNEN\<2cm within 12 months. In these cases, diagnosis has to be proven by histological confirmation of NF-PNEN * Informed consent
Exclusion criteria
* NF-PNEN \> 2 cm of maximum diameter * Presence of genetic syndrome (MEN1, VHL, NF) * Presence of symptoms (specific symptoms suspicious of a clinical syndrome related to hypersecretion of bioactive compounds) or unspecific symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease/progression-free survival of NF-PNEN ≤ 2 cm | From date of enrolment until the date of first documented progression or first evidence of recurrence, from 6 months up to 6 years. | The 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 (surgical resection group) or death from disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of NF-PNEN ≤ 2 cm | 6 years | The secondary end point is to evaluate the frequency of asymptomatic sporadic NF-PNEN ≤ 2 cm among overall sporadic NF-PNEN. Participating centers are required to give yearly the number of patients with NF-PNEN referred to their institution. |
| Outcome of surgical intervention of NF-PNEN ≤ 2 cm | from the date of surgery to 1 months later the surgery | Morbidity and mortality of patients submitted to surgical resection |
| Epidemiology of patients submitted to surgical intervention for NF-PNEN ≤ 2 cm | from the date of surgery, up to 6 years | Number of patients submitted to surgery andh type of surgical procedures. |
| Evolution of NF-PNEN ≤ 2 cm | From date of enrolment until the date of first documented radiological evolution, from 6 months up to 6 years. | NF-PNEN evolution, in terms of development of symptoms, tumour growth, development of distant metastases and secondary pancreatic duct dilatation. |
| Quality of Life of NF-PNEN ≤ 2 cm | from 6 months up to 6 years. | The perceived burden of surveillance or follow-up after surgery for participants, as assessed by questionnaires regarding attitude towards surveillance and general anxiety and depression (Hospital Anxiety and Depression scale, HADS). Quality of Life will be investigated, by filling in EORTC QLQ-C30 (version 3) and EORTC QLQ-GI.NET21 Module. |
Countries
Italy
Contacts
Primary ContactMassimo Falconi, Professor
Backup ContactStefano Partelli, MD PhD
Outcome results
None listed