Pancreatic Neuroendocrine Tumors, WHO Grade I-II
Conditions
Brief summary
A national multicenter prospective study to investigate the feasibility and efficacy of endoscopic ultrasound guided radiofrequency ablation of neuroendocrine pancreatic tumors, WHO Grade 1-2 of 3 cm or less in diameter.
Interventions
DEVICERadio frequency ablation
Radio frequency ablation of pancreatic neuroendocrine tumors
Sponsors
Haukeland University Hospital
St. Olavs Hospital
University Hospital of North Norway
Oslo University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age above 18 * EUS fine needle biopsy (FNB) proven pancreatic neuroendocrine tumor (PNET), WHO 2019 Grade 1-2 in patients with functioning or non-functioning tumors. Also MEN1 patients are eligible: * PNET 2-3 cm in largest diameter (Based on MRI or CT) with a Ki-67 \<5%, or: * PNET \< 2cm with Ki-67 \<10% that has shown progression during surveillance, or: * PNET 1.5-2 cm with Ki-67 \<10% in patients age \< 60 years of age, whether progression is detected or not. * Distance from the main pancreatic duct ≥2 mm, or \<2mm with a prophylactic stent in the main pancreatic duct. * Patient in good general condition, ECOG performance status 0-2 (see Appendix) * Signed written informed consent
Exclusion criteria
* Pregnancy. * Life expectancy \< 1 year * Severe hemostasis disorders * Pancreatic and/or biliary ductal dilation * Evidence of active pancreatitis * Metastatic disease, including local lymph node metastases * Use of anticoagulants that cannot be discontinued * INR \>1.5 or platelet count \<50.00 * Distance from the main pancreatic duct \<1 mm, and placement of a pancreatic stent is not possible * Patient being managed for another malignant lesion which is progressive or under treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Up to 12 months | To register number of patient experiencing adverse events to the radiofrequency ablation procedure |
| Residual disease | Up to 5 years | To register number of patient who develop residual disease in the area of the tumor that has been treated with radiofrequency ablation |
| Metastatic disease | Up to 10 years | To register number of patient who develop of local or distant metastases |
Countries
Norway
Contacts
Primary ContactEspen Thiis-Evensen, MD, PhD
Backup ContactJon Sponheim, MD. PhD
Outcome results
None listed