Clinical trial NCT04520932: Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors
Official title: Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Low Grade Pancreatic Neuroendocrine Tumors of Less Than 2cm in Size
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuroendocrine Tumor of Pancreas (Disorder)
Neuroendocrine Tumor Grade 1
Keywords: Radio Frequency treatment
Echoendoscopy
Ablation
Efficacy
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 included in the study after signing the consent. They will benefit from a RFA treatment consisting of 1 to 3 sessions depending on their response to the treatment. Patients will then be followed for 5 years in order to evaluate their response to treatment, their clinical evolution, their quality of life and any complications.

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment response
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
Study officials:
affiliation: Paoli Calmettes Institute
name: Fabrice CAILLOL, MD
role: PRINCIPAL_INVESTIGATOR
References: