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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neuroendocrine Tumor Grade 1; Neuroendocrine Tumor of Pancreas (Disorder)
• Intervention / Treatment: Procedure: Radiofrequency ablation

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 Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominique GENRE, MD; Phone Number: +33491223778; Email: drci.up@ipc.unicancer.fr

Study Locations

• France
  • Marseille, France, 13009
    • Recruiting
    • Institut Paoli Calmettes
    • Contact: GOUARNE Caroline, PhD; Phone Number: + 33 4 91 22 37 78; Email: drci.up@ipc.unicancer.fr
    • Contact: GENRE Dominique, MD; Phone Number: + 33 4 91 22 37 78; Email: drci.up@ipc.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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®.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes
• Investigators: Principal Investigator: Fabrice CAILLOL, MD, Paoli Calmettes Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2021
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2031

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Efficacy; Ablation; Radio Frequency treatment; Echoendoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Pancreatic Diseases; Neoplasms; Pancreatic Neoplasms; Neuroendocrine Tumors
• Other Study ID Numbers: RFANET-IPC 2020-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No