NCT06957600

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

Navigational Bronchoscopy Versus CT-Guided Radioisotope Markings: A Randomized Controlled Trial of Preoperative Localization in Uniportal VATS Wedge Resections

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Semmelweis University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• VATS
• Lung
• ICG (Indocyanine Green)

Interventions

Type	Name	Description
PROCEDURE	Preoperative marking	Applying markings prior to uniport VATS wedge resections helps localize small, potentially early-stage lung tumors. After marking, the patients are positioned laterally and receive general anesthesia with single-lung ventilation. The investigators perform VATS wedge resection using uniportal techniques. The utility incision is made in the 5th intercostal space between the anterior and mid-axillary lines. Insufflation is not typically utilized. The lesion is localized, elevated, and confirmed by palpation. The investigators then staple around the lesion using the Endo GIA™ ultra universal stapler with an Articulating Reload featuring Tri-Staple™ Technology in 45 or 60 mm lengths, choosing purple or black loads based on parenchyma thickness. Finally, the investigators close the wound and place one chest drain in the thoracic cavity, set to active suction of 5-10 cm of water.

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-08-26
• Completion: 2025-08-26
• First posted: 2025-05-04
• Last updated: 2025-09-05

Locations

1 site across 1 country: Hungary