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

University of Oslo (UIO)

Status

Enrolling

Conditions

Pancreatic Neuroendocrine Tumors, WHO Grade I-II

Treatments

Device: Radio frequency ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT05243082

280305

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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