Endoscopic Ultrasound-guided Fine-needle Injection for Multiple Endocrine Neoplasia Type 1-related 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
- Changes of blood glucose level
研究概览
简要总结
The present study aims to evaluate the feasibility, safety and efficacy of EUS-FNI for MEN1-related pNETs
详细描述
The management of multiple endocrine neoplasia type 1 (MEN1-1)-related pancreatic neuroendocrine tumors (pNETs) remains controversial. In general, surgical resection is currently the first-line therapy for MEN1-1-related pNETs. However, the surgical resection of pNETs is conditional for specific patients, and the incidence of postoperative adverse events is still high. Recently, several studies have demonstrated that endoscopic ultrasonography (EUS)-guided fine-needle injection (EUS-FNI) with ethanol or lauromacrogol may provide an alternative to surgical resection of pNETs. Nevertheless, their sample size was relatively small and conclusions were drawn based on short-term results. Therefore, a multicenter prospective study is being performed to further access the efficacy and safety of EUS-FNI for MEN1-1-related 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 MEN1-1-related pNETs are evaluated by histopathology and genetic testing.
- •Patients who refuse surgery.
- •Patients who have given their fully informed consent.
排除标准
- •Patients who are not suitable for the endoscopic procedure.
- •Patients who have blood coagulation dysfunction, mental disorders, mild or severe cardiorespiratory.
结局指标
主要结局
Changes of blood glucose level
时间窗: Within 7 days of the last ablation and every 6 months up to 24 months
Changes in the lowest blood glucose levels between baseline and last treatment and each study visit
Changes of insulin level
时间窗: Within 7 days of the last ablation and every 6 months up to 24 months
hanges in the insulin levels between baseline and last treatment and each study visit
Changes of C peptide
时间窗: Within 7 days of the last ablation and every 6 months up to 24 months
Changes in the C peptide levels between baseline and last treatment and each study visit
Imaging response
时间窗: Every 6 months up to 24 months
Complete ablation on the CE-CT or CE-EUS
次要结局
- Feasibility of EUS-FNI(At the time of procedure)
- Safety of EUS-FNI(Within 1 month after treatment)
研究者
Shanyu Qin
Professor
Guangxi Medical University