Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms
Recruiting · NCT05243082 · Interventional (participants receive a specific treatment) · Lead sponsor: Oslo University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Radio frequency ablation
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Oslo University Hospital - Oslo, Norway