Status:
RECRUITING
Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors
Lead Sponsor:
Institut Paoli-Calmettes
Conditions:
Neuroendocrine Tumor of Pancreas (Disorder)
Neuroendocrine Tumor Grade 1
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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...
Detailed Description
The primary objective of the study is to evaluate the efficacy of radiofrequency treatment of grade 1 NF-PNETS with a size less than or equal to 2cm. Patients meeting the selection criteria will be i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2031
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04520932
Start Date
March 30 2021
End Date
April 1 2031
Last Update
May 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institut Paoli Calmettes
Marseille, France, 13009