Asymptomatic Small Pancreatic Endocrine Neoplasms.

Launched by IRCCS SAN RAFFAELE · Mar 14, 2017

Keywords

ClinConnect Summary

This clinical trial is looking at how to best manage small, non-functioning pancreatic tumors that are less than 2 cm in size. These tumors, known as non-functioning pancreatic endocrine neoplasms (NF-PNEN), are often found by chance and do not cause symptoms. The study will help doctors decide whether patients should have surgery to remove the tumor or if they can simply be monitored over time, a process called active surveillance. The trial is currently recruiting participants, who can be anyone over the age of 18.

To join the trial, patients must have a confirmed diagnosis of NF-PNEN that is 2 cm or smaller, either through a fine-needle aspiration test or certain imaging scans. Those who are already scheduled for surgery for their small tumors within the past year can also participate. However, individuals with larger tumors, certain genetic syndromes, or any symptoms related to these tumors will not be eligible. Participants will work closely with their doctors, who will guide them through the best management plan based on their individual situation.

Gender

ALL

Eligibility criteria

• 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