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

Neuroendocrine Tumor Grade 1 Clinical Trial

— RFANET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04520932
• Other study ID #: RFANET-IPC 2020-003
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2021
• Est. completion date: April 2031

Study information

• Verified date: April 2024
• Source: Institut Paoli-Calmettes
• Contact: Dominique GENRE, MD
• Phone: +33491223778
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: April 2031
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Neuroendocrine Tumor Grade 1
• Neuroendocrine Tumor of Pancreas (Disorder)
• Neuroendocrine Tumors
• Pancreatic Neoplasms

Intervention

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®.

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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