DRKS00007163已完成未知
Safety and effectiveness of microwave ablation (MWA)as a new thermal ablation technique for lungmalignancies (SAMANTHA) - SAMANTHA
Otto-von-Guericke-Universität MagdeburgMedizinische Fakultät0 个研究点目标入组 36 人开始时间: 2016年5月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Primary lung cancer (NSCLC)
- •o Functional irresectable
- •FEV1 < 30% and/or
- •diffusion capacity <30% and/or
- •mx. O2-uptake in spiro-ergometry < 15% and/or
- •EF<30% in echocardiography
- •oRefusal of surgical treatment by patient
- •oInterdisciplinary decision for microablative treatment
- •2. Secondary lung malignancies
- •oInterdisciplinary decision for microablative treatment
- •- Age > 18 years
- •- Tumor size between 5mm and 50mm
- •- Positive proof of vitality:
- •oFDG-uptake in FDG-PET-CT (positive biopsy needed in case of doubts in a positive PET finding in interdisciplinary consensus)
- •osize increase of target lesion in CT
- •opositive biopsy of the target lesion
- •- Distance between target lesion and heart > 20mm
排除标准
- •- Life expectancy <13 month
- •- Contraindications for a CT-guided intervention
- •- Contraindications for a microwave ablation
- •- Abnormal bleeding parameters (PTT < 50%; platelet count < 50x109/L)
- •- Respiratory insufficiency (pO2 < 60 or pCO2 > 45)
- •- Myocardial infarction or stroke within 2 month before intervention
研究者
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