Application of a New System of Ultrasound (US) Guided - Radiofrequency Ablation (RFA) on Explanted Pancreas From Patients With Solid Pancreatic Masses: Study of Efficacy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- diameter (millimeters) of coagulative necrosis obtained by RadioFrequency Ablation
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
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)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •pancreatic solid lesion presence (pancreatic adenocarcinoma and neuroendocrine tumors) resected during pancreatic surgery -
Exclusion Criteria
- •no signature on informed consent
Outcomes
Primary Outcomes
diameter (millimeters) of coagulative necrosis obtained by RadioFrequency Ablation
Time Frame: within 15-20 days
assesses by two blinded pathologists
Secondary Outcomes
No secondary outcomes reported
Investigators
Paolo Giorgio Arcidiacono, MD
Professor
IRCCS San Raffaele