An interventional study of Monarch RAB with CBCT-guided ICG Dye Marking in Small Pulmonary Nodules, Pulmonary Nodule Localization and Lung Cancer (Suspected or Confirmed), sponsored by Peking University Cancer Hospital & Institute. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by Peking University Cancer Hospital & Institute · Not applicable, Interventional, and Treatment
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.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 3,656 interventional studies indexed under Lung Neoplasms.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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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).
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.
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 (%).
Time frame: 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 (%).
Time frame: 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 (%).
Time frame: Perioperative (during VATS)
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.
Time frame: Through study completion, up to 8 months
Bronchoscopy-related complication rate
Incidence of pneumothorax, bleeding, and respiratory failure related to bronchoscopy, graded according to CTCAE. participants (%).
Time frame: 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.
Time frame: During index hospitalization
No study locations are listed for this record.
Plan to share: No
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This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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