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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Monarch RAB + CBCT-guided ICG Localization + VATS Sublobectomy | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monarch RAB with CBCT-guided ICG Dye Marking | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of 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 (%). | Periprocedural( localization procedure) |
| Success rate of effective localization | 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 (%). | Perioperative (during VATS) |
| Success rate of VATS sub-lobar resection | 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 (%). | Perioperative (during VATS) |
| Measure | Description | Time Frame |
|---|---|---|
| Learning curve for localization | Number of cases required for surgeon to achieve proficiency using cumulative sum (CUSUM) method based on OT1 and localization success rate.Unit of Measure: case number. | Through study completion, up to 8 months |
| Bronchoscopy-related complication rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bingyang Huang | Contact | +8613161541915 | bingyanghuang@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Shaohua Ma | Peking University Cancer Hospital & Institute, Beijing 100142, China | Principal Investigator |
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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.
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Incidence of pneumothorax, bleeding, and respiratory failure related to bronchoscopy, graded according to CTCAE. participants (%). |
| From end of bronchoscopy through Postoperative Day 14. |
| Health economic outcomes | Includes postoperative hospital stay, total hospitalization cost, complication treatment cost, anesthesia cost, and localization procedure cost. Unit of Measure: CNY. | During index hospitalization |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D055613 | Multiple Pulmonary Nodules |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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