The Comparison of Navigational Bronchoscopic and CT-Guided Preoperative Markings in Minimally Invasive Thoracic Surgery (NaviGuide)

Semmelweis University

Status: Begins enrollment this month

Conditions: ICG (Indocyanine Green); Lung; VATS

Treatments: Procedure: Preoperative marking

Study type: Interventional

Funder types: Other

Identifiers

NCT06957600

2025-522130-31-00 (EU Trial (CTIS) Number)

BMEÜ/2368-1/2022/EKU

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 81 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 2 patient groups

Navigational bronchoscopy

Active Comparator group

Description:

For electromagnetic navigational bronchoscopic markings, the investigators use the Medtronic SuperDimension system. The process starts with a planning phase in which a thin-sliced (0.8-1.25 mm) CT scan is uploaded into the software, segmenting the airways and reconstructing the bronchial tree, allowing us to plan the best route to the lesion. During the procedure, the patient lies supine on a board emitting a low-frequency electromagnetic field. An Olympus™ bronchoscope with an extended working channel (EWC) is employed, and a locatable guide is placed into the airway. Registration matches the patient's airway to the virtual bronchial tree. Once the investigators reach the lesion, they secure the EWC and administer 2 ml of ICG 5 mg/ml solution through a 21G TBNA needle to mark it. After removing the bronchoscope, selective intubation is performed. The investigators proceed to surgery using a near-infrared Olympus optic.

Treatment:

Procedure: Preoperative marking

CT guided markings

Active Comparator group

Description:

Localization of lung lesions before surgery using CT-guided transthoracic 99mTc isotope placement (CTI) follows a specific protocol. The investigators prepare 99mTc-MAA using macroalbumin and Tc-99m, targeting 220-240 MBq in 3 ml and administering 14-16 MBq (0.2 ml) while considering the remaining syringe volume. An interventional radiologist performs the marking on the same day as the surgery, ideally in the morning. Patients are positioned for easy access to the lesion. Native CT images confirm nodule localization. Local anesthetic, typically 20 ml of 10 mg/ml Lidocaine, is injected after confirming the entry point with a 22G needle. The isotope is injected through a 15 cm 22G applicator. A final CT scan checks for complications before transferring the patient for surgery. In the operating theater, the Europrobe detects the nodule marked prior to wedge resection. Isotope marking occurs two hours before surgery, with repetition required if more than six to eight hours elapse.

Treatment:

Procedure: Preoperative marking