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.
Age 18-80 years
Clinically indicated sub-lobar resection
Tolerates general anesthesia
Single/multiple small nodules <20 mm in peripheral lung field
Contraindications to bronchoscopy/anesthesia
Coagulopathy or bleeding tendency
Implanted devices interfering with navigation
Allergy to ICG or iodinated contrast
Single group
Monarch RAB with CBCT-guided ICG Dye Marking
Procedure/SurgeryUnder general anesthesia, the Monarch RAB platform is used to navigate to the target bronchus. With CBCT confirmation, 0.25 ml of ICG (0.2 mg/ml) mixed with 0.25 ml iodinated contrast is injected within 1 cm of the nodule. The dye marking is identified intraoperatively with near-infrared light to guide VATS sublobectomy.
Success rate of 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
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
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 (%).
Learning curve for localization
Number of cases required for surgeon to achieve proficiency using cumulative sum (CUSUM) method based on OT1 and localization success rate.Unit of Measure: case number.
Bronchoscopy-related complication rate
Incidence of pneumothorax, bleeding, and respiratory failure related to bronchoscopy, graded according to CTCAE. participants (%).
Health economic outcomes
Includes postoperative hospital stay, total hospitalization cost, complication treatment cost, anesthesia cost, and localization procedure cost. Unit of Measure: CNY.
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