RecruitingNot ApplicableNCT04520932

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

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

Sponsor

Institut Paoli-Calmettes

Enrollment

82 participants

Start Date

Mar 30, 2021

Study Type

INTERVENTIONAL

Conditions

Neuroendocrine Tumor Grade 1 Neuroendocrine Tumor of Pancreas (Disorder)

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether radiofrequency ablation performed through an endoscope (a camera inserted into your digestive tract) can safely destroy small, slow-growing neuroendocrine tumors of the pancreas, as an alternative to surgery or ongoing monitoring. **You may be eligible if...** - You have a pancreatic mass smaller than 2 cm confirmed on MRI or CT scan - A biopsy has confirmed a slow-growing neuroendocrine tumor (Ki67 less than 3%) - The tumor is not producing hormones and causing symptoms - You are between 18 and 80 years old and in good general health **You may NOT be eligible if...** - The tumor is near the main pancreatic or bile ducts - The cancer has spread to lymph nodes or other organs - You have severe blood clotting problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERadiofrequency ablation

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