Application of a New System of Ultrasound (US) Guided - Radiofrequency Ablation (RFA) on Explanted Pancreas From Patients With Solid Pancreatic Masses: Study of Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- diameter (millimeters) of coagulative necrosis obtained by RadioFrequency Ablation
研究概览
简要总结
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).
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
pathologists (two different pathologist blinded about the power of RFA applied and respect to the other pathologist) will evaluate the effect of ablation (coagulative necrosis at microscopic evaluation)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pancreatic solid lesion presence (pancreatic adenocarcinoma and neuroendocrine tumors) resected during pancreatic surgery -
排除标准
- •no signature on informed consent
研究组 & 干预措施
resected PDAC without neoadjuvant chemotherapy treatment
Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
干预措施: ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions (Procedure)
resected PDAC without neoadjuvant chemotherapy treatment
Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
干预措施: ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions (Procedure)
resected PDAC without neoadjuvant chemotherapy treatment
Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
干预措施: ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions (Procedure)
resected PDAC with neoadjuvant chemotherapy treatment
Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
干预措施: ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions (Procedure)
resected PDAC with neoadjuvant chemotherapy treatment
Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
干预措施: ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions (Procedure)
resected PDAC with neoadjuvant chemotherapy treatment
Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
干预措施: ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions (Procedure)
resected neuroendocrine tumors
Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
干预措施: ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions (Procedure)
resected neuroendocrine tumors
Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
干预措施: ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions (Procedure)
resected neuroendocrine tumors
Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
干预措施: ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions (Procedure)
结局指标
主要结局
diameter (millimeters) of coagulative necrosis obtained by RadioFrequency Ablation
时间窗: within 15-20 days
assesses by two blinded pathologists
次要结局
未报告次要终点
研究者
Paolo Giorgio Arcidiacono, MD
Professor
IRCCS San Raffaele