NCT05243082Recruiting
Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms
Source: ClinicalTrials.gov · Last updated 30 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 14 Jan 2022
- Start date
- 14 Jan 2022
- Primary completion date
- 14 Jan 2025
- Lead sponsor
- Oslo University Hospital
- Diseases
- Neuroendocrine tumours, Pancreatic cancer
- NCT number
- NCT05243082
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 14 Jan 2022 to the primary completion date, 14 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe hemostasis disorders
- Metastatic disease, including local lymph node metastases
- Patient being managed for another malignant lesion which is progressive or under treatment
Lab values
- INR \>1.5 or platelet count \<50.00
Other
- Pregnancy.
- Life expectancy \< 1 year
- Pancreatic and/or biliary ductal dilation
- Evidence of active pancreatitis
- Use of anticoagulants that cannot be discontinued
- Distance from the main pancreatic duct \<1 mm, and placement of a pancreatic stent is not possible
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.