NCT02816944Unknown1 期
Effectivity and Safety of Endoscopic Ultrasonography-guided Laser Ablation for Refractory Neoplasms
First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年5月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 80 patients of refractory neoplasms with EUS-guided laser ablation-related effectivity as assessed by MRI
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of endoscopic ultrasonography (EUS) guided laser ablation liver, pancreas, and retroperitoneal tumors, the investigators used preoperative and postoperative US/CEUS/CT/MRI to assess lesions, and laboratory tests including the tumor markers to evaluate the general condition of patients. Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with refractory neoplasms including small hepatocellular carcinoma adjacent to the gastrointestinal tract, pancreatic neuroendocrine tumor, retroperitoneal tumor with less than 3 cm in diameter;
- •Patients with Child-Pugh A/B;
- •Patients with PLT ≥ 50*10E9/L and PT ≤ 20s.
排除标准
- •Patients with severe cardiopulmonary disease, intolerant endoscopy and anesthesia, upper gastrointestinal bleeding in shock, corrosive esophagitis and acute gastritis.
结局指标
主要结局
80 patients of refractory neoplasms with EUS-guided laser ablation-related effectivity as assessed by MRI
时间窗: up to 24 months
次要结局
未报告次要终点
研究者
研究点 (1)
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