Ex-vivo Ultrasound Guided Radiofrequency Ablation on Pancreatic Solid Lesions

San Donato Group (GSD)

Status: Terminated

Conditions: Radiofrequency Ablation; Endoscopic Ultrasound; Pancreatic Cancer

Treatments: 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 50 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

Study type: Interventional

Funder types: Other

Identifiers

NCT06371716

EUS-RFA ex-vivo 2016

Details and patient eligibility

About

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).

Full 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

Enrollment: 45 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria: no signature on informed consent

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

resected PDAC without neoadjuvant chemotherapy treatment

Experimental group

Description:

Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)

Treatment:

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 50 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

resected PDAC with neoadjuvant chemotherapy treatment

Experimental group

Description:

Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)

Treatment:

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 50 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

resected neuroendocrine tumors

Experimental group

Description:

Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)

Treatment:

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 50 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