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Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors

RecruitingNAAges 18 Years - 80 YearsAllInstitut Paoli-Calmettes
NCT04520932 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Pancreatic radiofrequency ablation (RFA) could therefore be an alternative to the monitoring of pancreatic neuroendocrine tumors (PNETs) and more particularly nonfunctioning PNETs (NF-PNETs), which is costly and anxiety-inducing for patients. To date, only a few small studies have evaluated this treatment and the results are encouraging. It appears necessary to consider a large-scale study to ensure the efficacy and low morbidity of pancreatic RFA applied to PNETs.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Pancreatic mass of less than 2cm on MRI, or CT scan if contraindicated by MRI; * Diagnosis of neuroendocrine tumor on biopsy under high echo-endoscopy (HEE) with Ki67\<3%, * Non-secretory lesion. * Homogeneous HEE contrast taking; * No positron emission tomography (PET) FDG binding to the pancreatic mass; * Lesion \<20mm on conventional imaging at 6 months monitoring; * Age 18 to 80 years inclusive; * Patient in good general condition, World Health Organization \[0-1\]; * Signed consent to participate; * Affiliation to healthcare insurance system or beneficiary of this regimen. Exclusion Criteria: * Pregnant or likely to become pregnant (without effective contraception) or breastfeeding ; * A person in an emergency situation or deprived of liberty or placed under the authority of a tutor. * Life expectancy \< 1 year; * Severe hemostasis disorders; * Pancreatic and/or biliary ductal dilation; * Lesion considered to be adjacent to the pancreatic duct and/or bile duct; * Node extension and/or metastatic disease; * Patient being managed for another malignant lesion which is progressive or under treatment.
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What it tests

  • Radiofrequency ablation
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Where

1 site
Institut Paoli Calmettes
Marseille, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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