Monarch Robotic Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS (REALM)

Peking University Cancer Hospital & Institute

Status: Not yet enrolling

Conditions: Pulmonary Nodule Localization; Video-assisted Thoracoscopic Surgery (VATS); Lung Cancer (Suspected or Confirmed); Small Pulmonary Nodules

Treatments: Procedure: Monarch RAB with CBCT-guided ICG Dye Marking

Study type: Interventional

Funder types: Other

Identifiers

NCT07177924

2025YJZ92

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Experimental: Monarch RAB + CBCT-guided ICG Localization + VATS Sublobectomy

Experimental group

Description:

All participants will undergo preoperative localization of small pulmonary nodules using indocyanine green (ICG) mixed with iodinated contrast agent under Monarch Robotic Assisted Bronchoscopy (RAB) with Cone-Beam CT (CBCT) guidance, performed by a single surgeon without prior RAB localization experience. Immediately after localization, patients will undergo video-assisted thoracoscopic surgery (VATS) sublobectomy (wedge resection or segmentectomy).

Treatment:

Procedure: Monarch RAB with CBCT-guided ICG Dye Marking