Clinical Trial: Asymptomatic Small Pancreatic Endocrine Neoplasms.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:

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.


Sponsor: IRCCS San Raffaele

Current Primary Outcome: Disease/progression-free survival of NF-PNEN ≤ 2 cm [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Frequency of NF-PNEN ≤ 2 cm [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: IRCCS San Raffaele

Dates:
Date Received: March 6, 2017
Date Started: March 1, 2017
Date Completion: March 31, 2023
Last Updated: March 14, 2017
Last Verified: March 2017