Effectiveness, Safety and Learning Curve of Monarch Robotic Assisted Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS Sublobectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Primary Endpoint
- Success rate of localization procedure
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Experimental: Monarch RAB + CBCT-guided ICG Localization + VATS Sublobectomy
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).
Intervention: Monarch RAB with CBCT-guided ICG Dye Marking (Procedure)
Outcomes
Primary Outcomes
Success rate of localization procedure
Time Frame: Periprocedural( localization procedure)
Calculated as (number of successful localization procedures ÷ total localization procedures) × 100%. Success is defined as ICG dye successfully injected at planned target site as confirmed by CBCT. Unit of Measure: participants (%).
Success rate of effective localization
Time Frame: Perioperative (during VATS)
Calculated as \[(number of successful localization procedures - number unrecognized in operative field) ÷ total localization procedures\] × 100%. Effective localization is defined as visible ICG staining on pleura during VATS. Unit of Measure: participants (%).
Success rate of VATS sub-lobar resection
Time Frame: Perioperative (during VATS)
Calculated as (number of successful VATS resections ÷ total localization procedures) × 100%. Successful VATS resection is defined as resection containing the complete lesion and the dye together. Unit of Measure: participants (%).
Secondary Outcomes
- Learning curve for localization(Through study completion, up to 8 months)
- Bronchoscopy-related complication rate(From end of bronchoscopy through Postoperative Day 14.)
- Health economic outcomes(During index hospitalization)