Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms (ERFA-PNET)

  • STATUS
    Recruiting
  • End date
    Nov 11, 2029
  • participants needed
    20
  • sponsor
    Oslo University Hospital
Updated on 23 March 2022
Accepts healthy volunteers

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.

Details
Condition Pancreatic Neuroendocrine Tumors, WHO Grade I-II
Treatment Radio frequency ablation
Clinical Study IdentifierNCT05243082
SponsorOslo University Hospital
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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