Ex-vivo Ultrasound Guided Radiofrequency Ablation on Pancreatic Solid Lesions
- Conditions
- Radiofrequency AblationPancreatic CancerEndoscopic Ultrasound
- Registration Number
- NCT06371716
- Lead Sponsor
- IRCCS San Raffaele
- Brief Summary
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).
- Detailed Description
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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 45
pancreatic solid lesion presence (pancreatic adenocarcinoma and neuroendocrine tumors) resected during pancreatic surgery -
no signature on informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method diameter (millimeters) of coagulative necrosis obtained by RadioFrequency Ablation within 15-20 days assesses by two blinded pathologists
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
IRCCS San Raffaele Hospital
🇮🇹Milan, Italy
IRCCS San Raffaele Hospital🇮🇹Milan, Italy