Monarch Robotic Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-10

Study Completion Date

2026-05-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-center, prospective, single-arm interventional study in which all enrolled patients with small pulmonary nodules difficult to localize during VATS will undergo preoperative indocyanine green (ICG) mixed with iodinated contrast dye marking under Monarch Robotic Assisted Bronchoscopy (RAB) with Cone-Beam CT (CBCT) guidance, immediately followed by VATS sublobectomy in the same operative session. The localization procedure is performed by a single surgeon without prior RAB localization experience to evaluate the learning curve.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Monarch RAB with CBCT-guided ICG Dye Marking

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No