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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
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
5 PDAC with neoadjuvant chemotherapy 5 PDAC without previous neoadjuvant chemotherapy 5 NETs
5 PDAC with neoadjuvant chemotherapy 5 PDAC without previous neoadjuvant chemotherapy 5 NETs
IRCCS San Raffaele Hospital
Milan, Italy
diameter (millimeters) of coagulative necrosis obtained by RadioFrequency Ablation
assesses by two blinded pathologists
Time frame: within 15-20 days
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