Monarch Robotic Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS

Effectiveness, Safety and Learning Curve of Monarch Robotic Assisted Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS Sublobectomy

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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