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Ex-vivo Ultrasound Guided Radiofrequency Ablation on Pancreatic Solid Lesions

Not Applicable
Terminated
Conditions
Radiofrequency Ablation
Pancreatic Cancer
Endoscopic 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
Inclusion Criteria

pancreatic solid lesion presence (pancreatic adenocarcinoma and neuroendocrine tumors) resected during pancreatic surgery -

Exclusion Criteria

no signature on informed consent

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
diameter (millimeters) of coagulative necrosis obtained by RadioFrequency Ablationwithin 15-20 days

assesses by two blinded pathologists

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

IRCCS San Raffaele Hospital

🇮🇹

Milan, Italy

IRCCS San Raffaele Hospital
🇮🇹Milan, Italy

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