Using ultrasound to guide radiofrequency treatment for pancreatic tumors
Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms
This study is testing if using ultrasound to guide a special heat treatment can safely target and destroy small pancreatic tumors in patients with certain types of neuroendocrine tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT05243082 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and effectiveness of using endoscopic ultrasound-guided radiofrequency ablation to treat pancreatic neuroendocrine tumors classified as WHO Grade 1-2, which are 3 cm or smaller. It is a national multicenter prospective study involving multiple hospitals to gather data on this innovative treatment approach. The goal is to assess how well this method can target and destroy tumor cells while minimizing damage to surrounding tissues.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 with specific types of pancreatic neuroendocrine tumors that meet the inclusion criteria.
Not a fit: Patients with severe health conditions, metastatic disease, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive option for patients with pancreatic neuroendocrine tumors, potentially improving outcomes and quality of life.
How similar studies have performed: While there is ongoing research in this area, this specific approach using endoscopic ultrasound-guided radiofrequency ablation for pancreatic neuroendocrine tumors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Study coordinator: Espen Thiis-Evensen, MD, PhD
- Email: ethiisev@ous-hf.no
- Phone: 45039399
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.