AHPBA Pancreatic Irreversible Electroporation (IRE) Registry for Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 16
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this study is to create a registry to provide insight into treatment selection and treatment outcome of pancreatic IRE in order to develop an evidence base such that physicians can provide the best possible care to patients with pancreatic cancer requiring surgical interventions.
The investigators seek a better understanding of the uses of ablation in the treatment of unresectable soft tissue pancreatic tumors and the limitations, concerns and complications that earlier users have.
详细描述
Rationale:
The rationale for creating this multi-center clinical database is to optimally collect clinical and pathological data on patients with neoplasms in order to facilitate future clinical observational and outcomes-based research.
Inclusion Criteria
Patients will be considered eligible for inclusion into the database if they meet the following eligibility criteria:
Evidence/suspicion of Pancreatic neoplasm ≥ 18 years of age
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Adult patients (greater than 18 years of age) diagnosed with pancreatic cancer that are eligible for soft tissue ablation per the treating physician.
排除标准
- •Have a cardiac pacemaker or ICD implant
- •Non-removable implants with metal parts near target lesion
- •Myocardial infarction within 3 months prior to enrollment
- •Not suitable for general endotracheal anesthesia
结局指标
主要结局
Adverse Events
时间窗: Up to 5 years
Prospective collection of All Adverse Events that will be categorized as either IRE related or Non-IRE related and will be graded per CTCAE v4.0
次要结局
- Overall Survival(Up to 5 years)
研究者
Robert C. Martin
Professor
University of Louisville