Ex-vivo Ultrasound Guided Radiofrequency Ablation on Pancreatic Solid Lesions

Not Applicable

Terminated

• Conditions: Radiofrequency Ablation; Pancreatic Cancer; Endoscopic Ultrasound
• Interventions: Procedure: ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions; Procedure: ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions; Procedure: ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions

• 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

Study Timeline

• Study Start: 2019-09-12
• Primary Completion: 2020-06-12
• Study Completion: 2020-06-12
• Study First Submitted: 2024-03-25
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-15
• Last Update Submitted: 2024-04-15
• Study First Posted: 2024-04-17
• Last Update Posted: 2024-04-17

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

Arm && Interventions

Group	Intervention	Description
resected PDAC with neoadjuvant chemotherapy treatment	ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions	Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
resected PDAC without neoadjuvant chemotherapy treatment	ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions	Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
resected PDAC with neoadjuvant chemotherapy treatment	ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions	Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
resected PDAC without neoadjuvant chemotherapy treatment	ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions	Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
resected neuroendocrine tumors	ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions	Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
resected neuroendocrine tumors	ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions	Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
resected PDAC without neoadjuvant chemotherapy treatment	ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions	Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
resected PDAC with neoadjuvant chemotherapy treatment	ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions	Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
resected neuroendocrine tumors	ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions	Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)

Primary Outcome Measures

Name	Time	Method
diameter (millimeters) of coagulative necrosis obtained by RadioFrequency Ablation	within 15-20 days	assesses by two blinded pathologists

Trial Locations

Locations (1)

IRCCS San Raffaele Hospital; 🇮🇹 Milan, Italy