Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms
NCT ID: NCT05243082
Last Updated: 2023-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2022-01-14
2029-11-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Historical controls
Historical controls
Radio frequency ablation
Radio frequency ablation of pancreatic neuroendocrine tumors
Interventions
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Radio frequency ablation
Radio frequency ablation of pancreatic neuroendocrine tumors
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Haukeland University Hospital
OTHER
St. Olavs Hospital
OTHER
University Hospital of North Norway
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Espen Thiis-Evensen
Senior consultant, MD, PhD
Locations
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Oslo University Hospital
Oslo, , Norway
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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280305
Identifier Type: -
Identifier Source: org_study_id
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