Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors
Recruiting now · Not applicable
Conditions studied: Neuroendocrine Tumor of Pancreas (Disorder), Neuroendocrine Tumor Grade 1
In brief
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.
Key facts
- Study ID
- NCT04520932
- Run by
- Institut Paoli-Calmettes
- People needed
- 82
- Starts
- 2021-03-30
- Expected to finish
- 2031-04-01
- Last updated by the study team
- 2025-05-25
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Institut Paoli Calmettes — Marseille, France (enrolling)
Full record on ClinicalTrials.gov
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