This is a Phase II Study on the Safety and Feasibility of Identifying the Intersegmental Plane of the Lung by Iron Sucrose Injection Staining,Both on the Pleural Surface and Lung Parenchyma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of treatment-related grade 3-5 adverse events
研究概览
简要总结
This is a protocol to determine the safety and feasibility of using Iron Sucrose Injection to identify the intersegmental plane,not only on the pleural surface but also the parenchyma of the lung.
详细描述
This is a protocol to determine the safety and feasibility of using Iron Sucrose Injection to identify the lung intersegmental plane. This is relevant because the detection of small and early lung cancer is becoming increasingly common. segmentectomy may become a more prominent procedure for early-small lung cancer. One of the most difficult aspects of complete segmentectomy is detection of the intersegmental plane while maintaining an adequate surgical margin and remaining lung function. The method used to detect the intersegmental plane remains controversial. It is hoped that this technology can be used to recognize the intersegmental plane on the pleural surface and the pulmonary parenchyma and will save lots of money for patients in developing countries.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years ≤age ≤80 years
- •The patient must be scheduled to undergo segmentectomy or combined subsegmentectomy.
- •The patient must be willing and able to comply with all study requirements and have understood and signed the informed consent.
排除标准
- •A known allergy to Iron Sucrose Injection
- •The patients who have Iron overdose or iron utilization barrier Intra-operative founding of extensive pigmentation Silicosis or extensive carbon deposition in the lung.
- •Patients who have not received segmental resection.
- •Patients who converted to thoracotomy.
研究组 & 干预措施
Iron Sucrose injection group
The investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) through a butterfly needle into the bronchus of the targeting segment.
干预措施: Iron Sucrose Injection (Drug)
结局指标
主要结局
Incidence of treatment-related grade 3-5 adverse events
时间窗: Up to 90 days post-surgery
Incidence of treatment-related grade 3-5 adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0
次要结局
- Surgical margin(Day of surgery)
研究者
Hecheng Li M.D., Ph.D
Head of Thoracic Surgery
Ruijin Hospital