Evaluating management options for small asymptomatic pancreatic tumors
A Prospective Evaluation of the Management of Sporadic Asymptomatic Nonfunctioning Pancreatic Neuroendocrine Neoplasms ≤ 2 cm
This study is testing whether people with small, non-symptomatic pancreatic tumors do better with surgery or just regular check-ups to see how they are doing.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT03084770 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the best management strategies for sporadic asymptomatic non-functioning pancreatic neuroendocrine neoplasms (NF-PNEN) that are 2 cm or smaller. Participants will either undergo surgical resection or be placed under active surveillance, with decisions made by their treating physicians. The study is based on recent findings suggesting that small NF-PNENs have a low risk of malignancy and can be safely monitored. The research will involve radiological imaging studies and quality of life assessments to evaluate patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with asymptomatic sporadic NF-PNEN measuring 2 cm or less.
Not a fit: Patients with NF-PNEN larger than 2 cm or those exhibiting symptoms related to the tumor may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into safer management options for patients with small pancreatic tumors, potentially avoiding unnecessary surgeries.
How similar studies have performed: Previous studies have indicated that conservative management for small NF-PNEN is safe, suggesting a promising approach for this study.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan
- IRCCS San Raffaele Hospital — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Massimo Falconi, Professor — IRCCS San Raffaele
- Study coordinator: Massimo Falconi, Professor
- Email: falconi.massimo@hsr.it
- Phone: 0039 022643 6046
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.