Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInstitut Paoli-Calmettes
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Radiofrequency ablation
Procedure/SurgeryRFA is performed under general anaesthesia, under high endoscopic echo-endoscopy (EEH), in left lateral decubitus position, using the StarMed generator from Taewong®.
Treatment groups
82 Participants
are divided into 1 treatment groupGroup A: RFA treatment efficacyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment response
Complete response rate to radiofrequency treatment defined by the absence of enhancement with the contrast agent and/or the disappearance of the lesion on imaging.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov