Clinical trial NCT06957600: The Comparison of Navigational Bronchoscopic and CT-Guided Preoperative Markings in Minimally Invasive Thoracic Surgery
Official title: Navigational Bronchoscopy Versus CT-Guided Radioisotope Markings: A Randomized Controlled Trial of Preoperative Localization in Uniportal VATS Wedge Resections
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: VATS
Lung
ICG (Indocyanine Green)
Keywords: VATS
ICG
navigational bronchoscopy
CT-guided radioisotope targeting
surgical margin
questionnaire
time
Lead sponsor: Semmelweis University
Sponsor class: OTHER
Collaborators: name: National Institute of Oncology, Hungary
First posted: 2025-05-04
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a prospective, single-center, randomized clinical trial comparing navigational bronchoscopic marking using indocyanine green dye (NAVIB) with CT-guided transthoracic marking using macroalbumin-aggregated Technetium-99 (CTI). The investigators plan to enroll patients with lung nodules measuring between 1 and 3 cm of unknown origin who are undergoing wedge resections.

In the surgical approach, the investigators exclusively utilize video-assisted techniques (VATS), and all operations in this trial are intended to be performed using a uniportal approach. This study adheres to the guidelines outlined in the Helsinki Declaration and complies with all local regulatory requirements. All participants provided informed consent before undergoing surgery. The procedures will be conducted in the Department of Thoracic Surgery at the National Institute of Oncology in Budapest, which is affiliated with Semmelweis University. All surgeries will be performed by experienced surgeons.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Time of Surgery
timeFrame: From the initiation of anesthesia to the completion of the surgery
measure: Surgical Satisfaction Survey
timeFrame: From the completion of surgery within 24 hours
Secondary outcomes:
measure: Complication rates
timeFrame: From the surgery up to 4 weeks
measure: Hospital stay (days)
timeFrame: From the surgery up to 4 weeks
measure: Tube duration days
timeFrame: From the surgery up to 4 weeks
measure: Conversion rates
timeFrame: During surgery
measure: The length of surgical margins in mm
timeFrame: Within 3 weeks after surgery
measure: The frequency of surgical margins greater than or equal to 10 mm
timeFrame: From the surgery in 3 weeks
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University- National Institute of Oncology Department of Thoracic Surgery
Study officials:
affiliation: Semmelweis
name: Áron Ghimessy, MD. PhD. MSc
role: STUDY_DIRECTOR
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