Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms

Recruiting now · Not applicable

Conditions studied: Pancreatic Neuroendocrine Tumors, WHO Grade I-II

In brief

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.

Key facts

Study ID

NCT05243082

Run by

Oslo University Hospital

People needed

20

Starts

2022-01-14

Expected to finish

2029-11-11

Last updated by the study team

2023-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Oslo University Hospital — Oslo, Norway (enrolling)

Full record on ClinicalTrials.gov

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