Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms (NCT05243082) | Clinical Trial Compass
RecruitingNot Applicable
Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms
Norway20 participantsStarted 2022-01-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.