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NCT Number: NCT04520932

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiofrequency ablation

Procedure

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

Primary outcomes

  1. Treatment response

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jihane PAKRADOUNI

CONTACT

[email protected]

+33491223778

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

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

Acronym: RFANET

Important dates

Study start
2021
Primary completion
2027
Study completion
2031
First posted
Aug 20, 2020
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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