A Prospective Evaluation of the Management of Sporadic Asymptomatic Nonfunctioning Pancreatic Neuroendocrine Neoplasms ≤ 2 cm
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Disease/progression-free survival of NF-PNEN ≤ 2 cm
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Disease/progression-free survival of NF-PNEN ≤ 2 cm
时间窗: 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.
次要结局
- Epidemiology of patients submitted to surgical intervention for NF-PNEN ≤ 2 cm(from the date of surgery, up to 6 years)
- 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.)
- Quality of Life of NF-PNEN ≤ 2 cm(from 6 months up to 6 years.)
- Frequency of NF-PNEN ≤ 2 cm(6 years)
- Outcome of surgical intervention of NF-PNEN ≤ 2 cm(from the date of surgery to 1 months later the surgery)
研究者
Massimo Falconi
full Professor
IRCCS San Raffaele