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

Sponsor
Institut Paoli-Calmettes (Other)
Overall Status
Recruiting
CT.gov ID
NCT04520932
Collaborator
(none)
82
1
1
120
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Radiofrequency ablation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
82 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Low Grade Pancreatic Neuroendocrine Tumors of Less Than 2cm in Size
Actual Study Start Date :
Mar 30, 2021
Anticipated Primary Completion Date :
Apr 1, 2027
Anticipated Study Completion Date :
Apr 1, 2031

Arms and Interventions

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®.

Outcome Measures

Primary Outcome Measures

  1. Treatment response [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut Paoli Calmettes Marseille France 13009

Sponsors and Collaborators

  • Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Fabrice CAILLOL, MD, Paoli Calmettes Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT04520932
Other Study ID Numbers:
  • RFANET-IPC 2020-003
First Posted:
Aug 20, 2020
Last Update Posted:
Jan 6, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institut Paoli-Calmettes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 6, 2022