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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04520932
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Institut Paoli-Calmettes
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Fabrice CAILLOL, MD
Principal Investigator Affiliation	Paoli Calmettes Institute
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroendocrine Tumor of Pancreas (Disorder), Neuroendocrine Tumor Grade 1

Additional Details

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.

Arms & Interventions

Arms

Experimental: RFA treatment efficacy

PNETs ablation by radiofrequency treatment (1 to 3 sessions)

Interventions

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®.

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