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resectable pancreatic adenocarcinoma and neuroendocrine pancreatic neoplasms are difficult to be enrolled. Pancreatic resectable cancers are treated nowadays with chemotherapy and big neuroedocrine pancreatic lesions rare
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The study investigates the feasibility and the efficacy to treat pancreatic solid lesions as pancreatic adenocarcinomas (PDAC) and neuroendocrine tumors (NET) with ex-vivo radiofrequency ablation (RFA) under ultrasound (US) control.
The study intent is to define the optimal radiofrequency ablation POWER of the system in terms of maximum sizes (diameters) of histological coagulative necrosis obtained at pathological samples. Results will be useful to define the optimal settings to ablate pancreatic solid lesions (PDAC and neuroendocrine tumours).
A probe specifically designed for Endoscopic Ultrasound (EUS) in vivo treatment of human pancreatic solid masses will be used. The probe is connected to a radiofrequency generator on which the power can be set and the tip of the probe (on the tip is present the radiofrequency electrode) is continuously perfused by chilled solution. The generator can stop the power supply when the tissue impedance goes beyond the threshold value to prevent tissue carbonization
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| resected PDAC without neoadjuvant chemotherapy treatment | Experimental | Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients) |
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| resected PDAC with neoadjuvant chemotherapy treatment | Experimental | Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients) |
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| resected neuroendocrine tumors | Experimental | Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions | Procedure | 5 PDAC with neoadjuvant chemotherapy treated at 10 W with ex-vivo RFA 5 PDAC without previous neoadjuvant chemotherapy treated at 10 W with ex-vivo RFA 5 NET treated at 10 W with ex-vivo RFA |
| Measure | Description | Time Frame |
|---|---|---|
| diameter (millimeters) of coagulative necrosis obtained by RadioFrequency Ablation | assesses by two blinded pathologists | within 15-20 days |
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Inclusion Criteria: pancreatic solid lesion presence (pancreatic adenocarcinoma and neuroendocrine tumors) resected during pancreatic surgery -
Exclusion Criteria: no signature on informed consent
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele Hospital | Milan | Italy |
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15 resected PDAC without neoadjuvant treatment 15 resected PDAC with neoadjuvant treatment 15 resected neuroendocrine tumors
Each group (15 patients each) Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
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pathologists (two different pathologist blinded about the power of RFA applied and respect to the other pathologist) will evaluate the effect of ablation (coagulative necrosis at microscopic evaluation)
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| ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions | Procedure | 5 PDAC with neoadjuvant chemotherapy 5 PDAC without previous neoadjuvant chemotherapy 5 NETs |
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| ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions | Procedure | 5 PDAC with neoadjuvant chemotherapy 5 PDAC without previous neoadjuvant chemotherapy 5 NETs |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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