NCT05243082
Recruiting
Not Applicable
Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms
Oslo University Hospital1 site in 1 country20 target enrollmentJanuary 14, 2022
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Neuroendocrine Tumors, WHO Grade I-II
- Sponsor
- Oslo University Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Adverse events
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Espen Thiis-Evensen
Senior consultant, MD, PhD
Oslo University Hospital
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
Outcomes
Primary Outcomes
Adverse events
Time Frame: Up to 12 months
To register number of patient experiencing adverse events to the radiofrequency ablation procedure
Residual disease
Time Frame: Up to 5 years
To register number of patient who develop residual disease in the area of the tumor that has been treated with radiofrequency ablation
Metastatic disease
Time Frame: Up to 10 years
To register number of patient who develop of local or distant metastases
Study Sites (1)
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