NCT05243082 Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms
| NCT ID | NCT05243082 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Pancreatic Neuroendocrine Tumors, WHO Grade I-II |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-01-14 |
| Primary Completion | 2025-01-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2022-01-14 with a primary completion date of 2025-01-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 or less in diameter.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05243082 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Neuroendocrine Tumors, WHO Grade I-II. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05243082 currently recruiting?
Yes, NCT05243082 is actively recruiting participants. Contact the research team at ethiisev@ous-hf.no for enrollment information.
Where is the NCT05243082 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT05243082 clinical trial?
NCT05243082 is sponsored by Oslo University Hospital. The trial plans to enroll 20 participants.