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Clinical Trials in France / NCT04520932
Recruiting Not applicable

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

NCT04520932 · tracked via the Priya Life Science France tracker
Sponsor
Institut Paoli-Calmettes
Phase
Not applicable
Started
2021-03-30
Last updated
2025-05-25

Condition(s) studied

Neuroendocrine Tumor of Pancreas (Disorder)Neuroendocrine Tumor Grade 1

Investigational drug(s) / intervention(s)

Radiofrequency ablation

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®.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Institut Paoli Calmettes Marseille France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04520932 on ClinicalTrials.gov ↗ ← All trials in France