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Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms

RecruitingNAAges 18 Years - anyAllOslo University Hospital
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ2 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
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What it tests

  • Radio frequency ablation
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Where

1 site
Oslo University Hospital
Oslo, Norway
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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