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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RFA treatment efficacy | Experimental | PNETs ablation by radiofrequency treatment (1 to 3 sessions) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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®. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment response | 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jihane PAKRADOUNI | Contact | +33491223778 | drci.up@ipc.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Fabrice CAILLOL, MD | Paoli Calmettes Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Paoli Calmettes | Recruiting | Marseille | 13009 | France |
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| ID | Term |
|---|---|
| D007516 | Adenoma, Islet Cell |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| D010190 |
| Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |