Monarch Robotic Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking University Cancer Hospital & Institute

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

Treatment groups

50 Participants
are divided into 1 treatment group

Locations

This trial has no locations