NCT06371716

Ex-vivo Ultrasound Guided Radiofrequency Ablation on Pancreatic Solid Lesions

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Pancreatic Cancer
• Endoscopic Ultrasound
• Radiofrequency Ablation

Interventions

Type	Name	Description
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
PROCEDURE	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
PROCEDURE	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

Timeline

• Start date: 2019-09-12
• Primary completion: 2020-06-12
• Completion: 2020-06-12
• First posted: 2024-04-17
• Last updated: 2024-04-17

Locations

1 site across 1 country: Italy