Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors
Recruiting · NCT04520932 · Interventional (participants receive a specific treatment) · Lead sponsor: Institut Paoli-Calmettes
View the official record on ClinicalTrials.gov →Interventions studied
Radiofrequency ablation
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Institut Paoli Calmettes - Marseille, France