Status:
RECRUITING
Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Haukeland University Hospital
St. Olavs Hospital
Conditions:
Pancreatic Neuroendocrine Tumors, WHO Grade I-II
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 11 2029
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05243082
Start Date
January 14 2022
End Date
November 11 2029
Last Update
March 30 2023
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway