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Monarch Robotic Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS
Sponsor: Peking University Cancer Hospital & Institute
Summary
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.
Official title: Effectiveness, Safety and Learning Curve of Monarch Robotic Assisted Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS Sublobectomy
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-10-10
Completion Date
2026-05-30
Last Updated
2025-09-17
Healthy Volunteers
No
Conditions
Interventions
Monarch RAB with CBCT-guided ICG Dye Marking
Under 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.