Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Low Grade Pancreatic Neuroendocrine Tumors of Less Than 2cm in Size

Conditions
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Neuroendocrine Tumor of Pancreas (Disorder), Neuroendocrine Tumor Grade 1

Intervention / Treatment
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* Procedure: Radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RFA treatment efficacy<br>PNETs ablation by radiofrequency treatment (1 to 3 sessions) | Procedure: Radiofrequency ablation<br>* RFA is performed under general anaesthesia, under high endoscopic echo-endoscopy (EEH), in left lateral decubitus position, using the StarMed generator from Taewong®.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radio Frequency treatment, Echoendoscopy, Ablation, Efficacy