About this trial
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.
Eligibility criteria
Qualifiers
Age 18-80 years
Clinically indicated sub-lobar resection
Tolerates general anesthesia
Single/multiple small nodules <20 mm in peripheral lung field
Disqualifiers
Contraindications to bronchoscopy/anesthesia
Coagulopathy or bleeding tendency
Implanted devices interfering with navigation
Allergy to ICG or iodinated contrast
Trial design
Treatments tested in this trial
- Monarch RAB with CBCT-guided ICG Dye Marking