Safety and Efficacy of Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA) in the Treatment of Pancreatic Lesions: A Pancardinal-4 Prospective Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of participants for whom there is technical success of tumor treatment
研究概览
简要总结
This is a 7-year prospective single-center registry study to assess the safety and efficacy of Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA) in the treatment of pancreatic lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of any pancreatic pre-malignant lesion and/or pancreatic malignancy
- •Patients already undergoing EUS-RFA for treatment of pancreatic lesions clinically
排除标准
- •Patients with co-existing malignancies of other organs (or a prior history of such)
- •Patients unable to provide informed consent
- •Patients unable to complete follow-up
结局指标
主要结局
Number of participants for whom there is technical success of tumor treatment
时间窗: From time of the procedure to about 3 months post procedure
Technical success of tumor treatment is defined as successful delivery of EUS-guided radiofrequency ablation (RFA) energy to the target pancreatic lesion with: * Accurate placement of the RFA probe within the intended lesion under EUS guidance * Completion of the planned ablation cycles * Immediate post-ablation sonographic evidence of treatment effect (e.g., hyperechoic changes within lesion indicating coagulative necrosis)
次要结局
- Number of participants with post-procedure complications observed within 30 days(from the time of the procedure to 30 days after the procedure)
- Reduction in the size of the tumor(baseline, 3 months, 6 months, 3 years)
- Reduction in systemic tumor markers(baseline, at the time of the first RFA (about 1 month after baseline), at the time of the second RFA (about 2 months after baseline), at the time of the third RFA (about 3 month after baseline))
研究者
Nirav C Thosani
Professor
The University of Texas Health Science Center, Houston