This clinical trial aims to determine whether navigational bronchoscopic or CT-guided marking is more effective for localizing small pulmonary nodules in minimally invasive thoracic surgery. It will also assess the safety of both methods. The main questions to answer are:

• Which of the two methods enables the surgeon to locate the lesion more quickly during surgery?
• Does using the newer navigational bronchoscopic method reduce the number of insufficient resections, meaning that the lesions were not completely removed, thus affecting the surgical margin?

Researchers will compare navigational bronchoscopic ICG (visible green dye on the screen) marking to CT-guided transthoracic radioisotope targeting (a substance that emits radiation and can be detected with a specific device) to evaluate whether bronchoscopy with ICG dye is equally effective or even superior without exposing patients to radiation.

Participants will:

• Undergo an additional procedure before surgery to make the lesions detectable (Preoperative marking).
• Proceed to surgery in accordance with standard practices.
• Visit the clinic once after three weeks for follow-up checks and tests.
• Grant access to the pathological results for researchers to analyze and store data.

Two different preoperative markings have proven invaluable for excising smaller pulmonary lesions. Electromagnetic navigation bronchoscopy (NAVIB) provides a more minimally invasive approach, particularly advantageous for centrally located lesions or patients with a higher risk of pneumothorax. CT-guided transthoracic radioisotope marking (CTI), on the other hand, is highly accurate for peripheral lesions and allows real-time confirmation of the marker's placement. However, it remains unclear whether one technique is superior under specific surgical conditions.

This study is a single-center, 1:1 randomized controlled trial evaluating whether NAVIB using indocyanine green dye or CTI with macroalbumin-aggregated technetium-99 99 is more effective for localization during uniportal wedge resections of lung nodules ranging from 10 to 30 mm. The primary endpoint is the duration of the surgical procedure, with secondary endpoints including complication rates, surgical margin, and surgeon satisfaction assessed through specific questionnaires.

The investigators have completed a running-up phase of the study and conducted a retrospective analysis of the data since 2022. They plan to randomize 81 patients, believing that ICG dye marking will facilitate the surgery, reduce operating time, and enhance the visibility of lung nodules. Based on preliminary data, the investigators expect an average time reduction of 10 minutes, with a standard deviation of 15 minutes. Using a power of 0.8 with a 0.05 alpha level, they determined that 74 patients are needed for the primary outcome. With an anticipated loss to follow-up or exclusions of 10%, the final target has been extended to 81 patients. Recruitment will begin once the trial has been registered internationally.

The results will be analyzed using a two-sided t-test for continuous variables (e.g., length of surgeries) and a chi-squared test for categorical variables when appropriate (e.g., complications and surgical margin positivity). In the questionnaire, the investigators will utilize a scale from 1 (not helpful) to 4 (very helpful) to assess surgeons' subjective preferences.

These results could help evaluate the safety and efficiency of both techniques, which is essential in choosing between the available marking methods and could aid in establishing new protocols.

In this study, patients with lung nodules between 10 and 30 mm (under clinical IC or lower stage if it was a case of NSCLC) who are fit for surgery will be enrolled. The investigators will collect epidemiological data, including age, race, gender, Charlson Comorbidity Index, smoking history, medications taken, previous surgeries, significant diseases, BMI, and detailed parameters of the radiological size of the tumor preoperatively. Within two months before surgery, the investigators will conduct a contrast-enhanced chest CT, which will include the upper abdomen and lung function tests (FVC, FEV1, DLCO). Patients who had previous thoracic surgery, are under 18 or over 85 years of age, or have FVC or FEV1 less than 60% will be excluded. Any patient unsuitable for the complete preoperative diagnostic procedure will also be excluded (for example, where contrast material is contraindicated in chronic kidney failure). Pathological parameters of the lesion will be evaluated within four weeks after surgery. Imaging will be conducted at least during the one-month follow-up to monitor complications.

Summary:

Inclusion Criteria:

• Aged from 18 to 85
• 1-3 cm lung nodules
• planned procedure VATS uniportal diagnostic wedge

Exclusion Criteria:

• Previous thoracic surgery
• CCI greater than 12
• Long-term steroid treatment

The investigators take data control seriously. In the investigator's initial approach, the investigator does not share patients' confidential data with any third party. The primary patient consent form was created with this principle in mind. Once the study is completed and demonstrates potential benefits for scientific purposes, the investigator may consider sharing the data if requested.

Randomization occurs before surgery and is stratified by the operating surgeon using a random permuted block design with block sizes of 2 and 4. This method ensures balance among the surgeons and prevents long runs of the same group. The pathologist responsible for assessing the resections will not have access to group assignments. In this trial, only the patients, the pathologist, and the statisticians will be blinded. Due to the nature of the techniques, it is not possible to blind the surgeons and operative staff since both methods require different equipment.