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NCT06371716 Clinical Trial

Ex-vivo Ultrasound Guided Radiofrequency Ablation on Pancreatic Solid Lesions

Pancreatic Cancer Clinical Trial

Official title:
Application of a New System of Ultrasound (US) Guided - Radiofrequency Ablation (RFA) on Explanted Pancreas From Patients With Solid Pancreatic Masses: Study of Efficacy

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT06371716
Other study ID # EUS-RFA ex-vivo 2016
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 12, 2019
Est. completion date June 12, 2020

Study information
Verified date April 2024
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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 information / eligibility
Status Terminated
Enrollment 45
Est. completion date June 12, 2020
Est. primary completion date June 12, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: pancreatic solid lesion presence (pancreatic adenocarcinoma and neuroendocrine tumors) resected during pancreatic surgery - Exclusion Criteria: no signature on informed consent -

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions
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
• ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions
5 PDAC with neoadjuvant chemotherapy 5 PDAC without previous neoadjuvant chemotherapy 5 NETs
• ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions
5 PDAC with neoadjuvant chemotherapy 5 PDAC without previous neoadjuvant chemotherapy 5 NETs

Locations
Country Name City State
Italy IRCCS San Raffaele Hospital Milan

Sponsors (1)
Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary diameter (millimeters) of coagulative necrosis obtained by RadioFrequency Ablation assesses by two blinded pathologists within 15-20 days
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