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

NCT ID: NCT04520932

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-30
• Study Completion Date: 2031-04-30

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.

Conditions

Neuroendocrine Tumor of Pancreas (Disorder); Neuroendocrine Tumor Grade 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RFA treatment efficacy

PNETs ablation by radiofrequency treatment (1 to 3 sessions)

Group Type: EXPERIMENTAL

Radiofrequency ablation

Intervention Type: PROCEDURE

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

Interventions

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®.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabrice CAILLOL, MD

Role: PRINCIPAL_INVESTIGATOR

Paoli Calmettes Institute

Locations

Institut Paoli Calmettes

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jihane PAKRADOUNI

Role: CONTACT

drci.up@ipc.unicancer.fr

+33491223778

Facility Contacts

Jihane PAKRADOUNI

Role: primary

drci.up@ipc.unicancer.fr

+ 33 4 91 22 37 78

Delphine MARIE

Role: backup

drci.up@ipc.unicancer.fr

+ 33 4 91 22 37 78

Other Identifiers

RFANET-IPC 2020-003

Identifier Type: -

Identifier Source: org_study_id