Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms

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.

Eligibility

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

Conditions2

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