临床试验/NCT02822053

NCT02822053Unknown1 期

Effectivity and Safety of Ultrasound-guided Percutaneously 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 100 人开始时间: 2016年4月1日最近更新: 2016年7月4日

适应症

试验速览

阶段: 1 期
发起方
入组人数: 100
试验地点: 1
主要终点: 100 patients of refractory neoplasms with image-guided laser ablation-related effectivity as assessed by MRI

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the safety and efficacy of ultrasonography (US) -guided laser ablation liver, kidney, pancreas, lung 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 small hepatocellular carcinoma (single or multiple nodules of 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 blood coagulation dysfunction, ChildPugh ≥3, severe cardiopulmonary disease, intolerant anesthesia and upper gastrointestinal bleeding in shock.

结局指标

主要结局

100 patients of refractory neoplasms with image-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

发起方

First Affiliated Hospital of Zhejiang University

申办方类型

Other

责任方

Sponsor

研究点 (1)

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