Endoscopic Ultrasound-guided Fine-needle Injection for Nonfunctional Pancreatic Neuroendocrine Tumors: a Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The rate of complete ablation
研究概览
简要总结
The current study aims to access the feasibility, safety, and efficacy of EUS-FNI for nonfunctional pNETs
详细描述
The management of nonfunctional pancreatic neuroendocrine tumors (NF-pNETs) remains controversial. In general, surgical resection is the standard treatment for NF-pNETs. However, the incidence of postoperative adverse events of surgical resection is relatively high. Recently, several studies have revealed that endoscopic ultrasonography (EUS)-guided fine-needle injection (EUS-FNI) with ethanol or lauromacrogol may offer an effective treatment for pNETs. Therefore, a multicenter prospective study is being conducted to further identify the efficacy and safety of EUS-FNI for NF-pNETs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with NF-pNETs are evaluated by cytology or immunohistochemistry.
- •Patients who refuse surgery or observation.
- •Patients who have given their fully informed consent.
排除标准
- •Patients who are not suitable for EUS-FNI.
- •Patients who have poor conditions including blood coagulation dysfunction, mental disorders, and mild or severe cardiorespiratory.
结局指标
主要结局
The rate of complete ablation
时间窗: At 24 months after treatment
The rate of complete ablation on the CE-CT or CE-EUS
The Chang The change of tumor size
时间窗: From baseline to 24 months
The change of tumor size on the CE-CT or EUS
次要结局
- Incidence of Treatment-Emergent Adverse Events(Within 3 month after treatment)
研究者
Shanyu Qin
Professor
Guangxi Medical University