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

Not Applicable

Recruiting

• Conditions: Neuroendocrine Tumor of Pancreas (Disorder); Neuroendocrine Tumor Grade 1
• Interventions: Procedure: Radiofrequency ablation

• Registration Number: NCT04520932
• Lead Sponsor: Institut Paoli-Calmettes

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.

Study Timeline

• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-20
• Study Start: 2021-03-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-25
• Primary Completion: 2027-04
• Study Completion: 2031-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 82

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RFA treatment efficacy	Radiofrequency ablation	PNETs ablation by radiofrequency treatment (1 to 3 sessions)

Primary Outcome Measures

Name	Time	Method
Treatment response	1 year	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.

Trial Locations

Locations (1)

Institut Paoli Calmettes; 🇫🇷 Marseille, France