Bronchoscopic ICG Injection vs Percutaneous Hook-wire Techniques for Preoperative Lung Nodule Localization in Video-assisted Thoracoscopic Sublobar Resection: A Prospective and Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Success rate of the localization procedure
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of transbronchial ICG and percutaneous hook-wire assisted Video-assisted thoracoscopic sublobar resection. In the control group, CT-guided percutaneous hook-wire preoperative localization will be used for surgical resection; In the experimental group, electromagnetic navigation bronchoscopy guided transbronchial ICG injection will be performed for localization before VATS.
详细描述
This is a single-center, prospective, randomized trial initiated by the investigator. Subjects with pulmonary nodules who will undergo Video-assisted thoracoscopic sublobar resection will be randomly divided into two groups. In the experimental group, before the VATS operation, transbronchial ICG injection will be guided by electromagnetic navigation bronchoscopy to locate the nodule. In the control group, the subject will undergo CT guided hook-wire placement for nodule localization before VATS. The study is expected to enroll 188 patients. Finally, the effectiveness and safety of the two methods will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Above 18 years old;
- •With lung nodule diameter ≤2cm and distance from pleura ≥1cm, and VATS sublobar resection is arranged;
- •Located difficultly by intraoperative visual inspection and palpation, a preoperative location is needed.
排除标准
- •Cardiopulmonary function cannot tolerate general anesthesia, or other contraindications, such as uncorrectable coagulopathy;
- •More than one pulmonary nodule requires preoperative localization;
- •Subject underwent thoracic surgery in the past and was suspected of having severe chest adhesions;
- •The nodule puncture path has bony structure block;
- •Others conditions that the investigator considers not appropriate for this trial.
研究组 & 干预措施
Bronchoscopic ICG localization
The nodule will be located preoperatively by ENB-Guided bronchoscopic ICG injection; During the VATS operation, a near-infrared fluorescence thoracoscopy will be used to identify ICG distribution in the visceral pleura to guide an accurate surgical resection.
干预措施: Indocyanine green (ICG) (Device)
Bronchoscopic ICG localization
The nodule will be located preoperatively by ENB-Guided bronchoscopic ICG injection; During the VATS operation, a near-infrared fluorescence thoracoscopy will be used to identify ICG distribution in the visceral pleura to guide an accurate surgical resection.
干预措施: Electromagnetic navigation bronchoscopy (Device)
percutaneous hook-wire localization
The nodule will be located preoperatively by percutaneous placement of hook wire; During the VATS operation, the resection scope is determined by the location relationship between hook wire and the nodule under CT scan.
干预措施: Hook wire (Device)
结局指标
主要结局
Success rate of the localization procedure
时间窗: On the 1 day of localization operation
Calculated as follows: (number of successful targeting procedures/number of all localization procedures)\*100
Success rate of the effective localization
时间窗: On the 1 day of VATS operation
Calculated as follows: \[(number of successful targeting procedures-number of dislodgements or unrecognized in the operative field)/number of all localization procedures\]\*100
Success rate of VATS sublobar resection
时间窗: On the 1 day of VATS completion
Calculated as follows: (number of successful VATS procedures/number of all localization procedures)\*100
次要结局
- Operation time of VATS sublobar resection(On the 1 day of VATS completion)
- Safety endpoint(On the 1 day of VATS operation)
- Localization time(On the 1 day of localization operation)
研究者
Jiayuan Sun
Director, Department of Endoscopy, Shanghai Chest Hospital
Shanghai Chest Hospital