Pancreatic Radiofrequency Under High Echo-endoscopy In The Management Of Pancreatic Neuroendocrine Tumors

Study Overview

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

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.

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.

Neuroendocrine Tumor of Pancreas (Disorder)
Neuroendocrine Tumor Grade 1

PROCEDURE: Radiofrequency ablation

RFANET-IPC 2020-003

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-08-17	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-23
First Submitted that Met QC Criteria 2020-08-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-25
First Posted (ACTUAL) 2020-08-20	Results First Posted N/A	Last Verified 2025-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: RFA treatment efficacy

PNETs ablation by radiofrequency treatment (1 to 3 sessions)

PROCEDURE: Radiofrequency ablation

RFA is performed under general anaesthesia, under high endoscopic echo-endoscopy (EEH), in left lateral decubitus position, using the StarMed generator from Taewong®.

Primary Outcome Measures	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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jihane PAKRADOUNI

Phone Number: +33491223778

Email: drci.up@ipc.unicancer.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Fabrice CAILLOL, MD, Paoli Calmettes Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record