Effectiveness, Safety and Learning Curve of Monarch Robotic Assisted Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS Sublobectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Success rate of localization procedure
研究概览
简要总结
This is a single-center, prospective, single-arm clinical study conducted at Beijing Cancer Hospital to evaluate the effectiveness, safety, and learning curve of preoperative indocyanine green (ICG) dye marking mixed with iodinated contrast agent under Monarch Robotic Assisted Bronchoscopy (RAB) with Cone-Beam CT (CBCT) for small pulmonary nodules that are difficult to locate during video-assisted thoracic surgery (VATS) sublobectomy. Eligible patients will undergo RAB localization immediately followed by VATS in the same operative session. The primary endpoints include the success rate of localization, effective localization, and VATS sublobar resection. Secondary endpoints include navigation success rate, operation times, reaching depth, complication rates, and health economic outcomes. The learning curve will be analyzed using the cumulative sum (CUSUM) method. A total of 50 patients will be enrolled and followed up for 14 days postoperatively.
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
- •Age 18-80 years
- •Clinically indicated sub-lobar resection
- •Tolerates general anesthesia
- •Single/multiple small nodules <20 mm in peripheral lung field
- •Nodules difficult to locate intraoperatively by inspection/palpation
排除标准
- •Contraindications to bronchoscopy/anesthesia
- •Coagulopathy or bleeding tendency
- •Implanted devices interfering with navigation
- •Allergy to ICG or iodinated contrast
- •Pregnant/lactating women
- •Intraoperative findings not suitable for procedure
结局指标
主要结局
Success rate of localization procedure
时间窗: Periprocedural( localization procedure)
Calculated as (number of successful localization procedures ÷ total localization procedures) × 100%. Success is defined as ICG dye successfully injected at planned target site as confirmed by CBCT. Unit of Measure: participants (%).
Success rate of effective localization
时间窗: Perioperative (during VATS)
Calculated as \[(number of successful localization procedures - number unrecognized in operative field) ÷ total localization procedures\] × 100%. Effective localization is defined as visible ICG staining on pleura during VATS. Unit of Measure: participants (%).
Success rate of VATS sub-lobar resection
时间窗: Perioperative (during VATS)
Calculated as (number of successful VATS resections ÷ total localization procedures) × 100%. Successful VATS resection is defined as resection containing the complete lesion and the dye together. Unit of Measure: participants (%).
次要结局
- Learning curve for localization(Through study completion, up to 8 months)
- Bronchoscopy-related complication rate(From end of bronchoscopy through Postoperative Day 14.)
- Health economic outcomes(During index hospitalization)