Monarch Robotic Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Monarch RAB with CBCT-guided ICG Dye Marking.
- Who it may be relevant to
- Registry conditions: Small Pulmonary Nodules, Pulmonary Nodule Localization, Lung Cancer (Suspected or Confirmed), Video-assisted Thoracoscopic Surgery (VATS). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness, Safety and Learning Curve of Monarch Robotic Assisted Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS Sublobectomy
Overview
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.
Interventions
- Procedure 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.
Primary outcome measures
- Success rate of localization procedure [Time frame: Periprocedural( localization procedure)]
- Success rate of effective localization [Time frame: Perioperative (during VATS)]
- Success rate of VATS sub-lobar resection [Time frame: Perioperative (during VATS)]
Secondary outcome measures (3)
- Learning curve for localization [Time frame: Through study completion, up to 8 months]
- Bronchoscopy-related complication rate [Time frame: From end of bronchoscopy through Postoperative Day 14.]
- Health economic outcomes [Time frame: During index hospitalization]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07177924 · 2025YJZ92