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2017-09-01
2024-08-31
2024-12-31
1000
NCT03084770
IRCCS San Raffaele
IRCCS San Raffaele
OBSERVATIONAL
Asymptomatic Small Pancreatic Endocrine Neoplasms.
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-03-06 | N/A | 2024-01-17 |
2017-03-14 | N/A | 2024-01-18 |
2017-03-21 | N/A | 2024-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Active surveillance group Advised surveillance strategy consists of imaging studies (MR or EUS or US), 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. During surveillance, a high-q | DIAGNOSTIC_TEST: Radiological imaging studies
OTHER: Quality of Life Assessment
|
| : Surgical resection group Timing and type of resection will be established by the treating physician. Follow up strategy after surgery consists of imaging studies (MR or CT), every 6 months for the first two years and yearly thereafter for five years. An high-quality imaging techn | DIAGNOSTIC_TEST: Radiological imaging studies
OTHER: Quality of Life Assessment
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Disease/progression-free survival of NF-PNEN ≤ 2 cm | 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. | From date of enrolment until the date of first documented progression or first evidence of recurrence, from 6 months up to 6 years. |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Frequency of NF-PNEN ≤ 2 cm | 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. | 6 years |
| Outcome of surgical intervention of NF-PNEN ≤ 2 cm | Morbidity and mortality of patients submitted to surgical resection | from the date of surgery to 1 months later the surgery |
| Epidemiology of patients submitted to surgical intervention for NF-PNEN ≤ 2 cm | Number of patients submitted to surgery andh type of surgical procedures. | from the date of surgery, up to 6 years |
| Evolution of NF-PNEN ≤ 2 cm | NF-PNEN evolution, in terms of development of symptoms, tumour growth, development of distant metastases and secondary pancreatic duct dilatation. | From date of enrolment until the date of first documented radiological evolution, from 6 months up to 6 years. |
| Quality of Life of NF-PNEN ≤ 2 cm | 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. | from 6 months up to 6 years. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Massimo Falconi, Professor Phone Number: 0039 022643 6046 Email: falconi.massimo@hsr.it |
Study Contact Backup Name: Stefano Partelli, MD PhD Phone Number: 0039 022643 7697 Email: partelli.stefano@hsr.it |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
