Clinical trial · NCT04520932
Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors
Sponsor: Institut Paoli-Calmettes
Summary
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.
Interventions
- Radiofrequency ablation · PROCEDURE
RFA is performed under general anaesthesia, under high endoscopic echo-endoscopy (EEH), in left lateral decubitus position, using the StarMed generator from Taewong®.
Published eligibility criteria
Verbatim from the registry. Only the site can decide how these apply to a specific patient.
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.
Sites (1)
- Institut Paoli Calmettes, Marseille, France · Recruiting
Not medical advice. Trial0 is a navigation service, not a medical provider. Nothing here is medical advice or a recommendation to pursue any treatment; eligibility matching is informational, based on published registry criteria, and only the trial site or treating clinician can determine actual eligibility. Decisions belong with the patient and their own doctors. Registry data refreshed at most hourly; last update posted 2025-05-25.