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

Not Applicable

Not yet recruiting

• Conditions: VATS; Lung; ICG (Indocyanine Green)

• Registration Number: NCT06957600
• Lead Sponsor: Semmelweis University

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.

Study Timeline

• Study First Submitted: 2025-04-26
• Study First Submitted QC: 2025-04-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-03
• Study First Posted: 2025-05-04
• Last Update Posted: 2025-05-07
• Study Start: 2025-06
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time of Surgery	From the initiation of anesthesia to the completion of the surgery	Time needed for completion of wedge resection in minutes
Surgical Satisfaction Survey	From the completion of surgery within 24 hours	The investigators assess the surgeons' experiences after the surgery using a questionnaire consisting of 9 questions, with answers on a scale from 1 to 4, where 1 is a poor outcome, 2 is neutral, 3 is acceptable, and 4 is a favorable outcome.; Questions: 1. How difficult was locating the lesion during the surgery?; 2. How challenging was the location of the lesion during the surgery?; 3. How challenging was taking out the lesion and positioning the stapler?; 4. How satisfied is the surgeon with the speed of the operation compared to the planned surgical time?; 5. After removal, did the resected specimen contain the lesion?; 6. Were there any issues with the marking? (e.g., gamma camera malfunction); 7. How effective was the preoperative marking in helping to locate the lesion?; 8. How accurately did the marking correspond to the actual location of the lesion?; 9. How satisfied was the surgeon with the quality of the marking overall?

Secondary Outcome Measures

Name	Time	Method
Conversion rates	During surgery	Conversion is defined as an anterolateral thoracotomy that is large enough to allow the surgeon's hand access to the thoracic cavity.
The length of surgical margins in mm	Within 3 weeks after surgery	The smallest distance between the lesion and the stapling line, also referred to as the surgical margin, is measured by the pathologist and expressed in mm.
Hospital stay (days)	From the surgery up to 4 weeks	The number of days between surgery and discharge
Tube duration days	From the surgery up to 4 weeks	The number of days after which the investigators can remove the thoracic drain.
Complication rates	From the surgery up to 4 weeks	Postoperative complications will be assessed based on the Ottawa Thoracic Morbidity \& Mortality score system, a thoracic complication scoring system that follows the principles of the Clavien-Dindo score.
The frequency of surgical margins greater than or equal to 10 mm	From the surgery in 3 weeks	It is considered an incomplete or suboptimal resection if the resection margins do not exceed 10 mm; it is also correlated with a higher recurrence rate. That is why the investigators create a binary variable: "yes" if the length of the surgical margin is greater than or equal to 10 mm, and "no" if it is smaller than that.

Trial Locations

Locations (1)

Semmelweis University- National Institute of Oncology Department of Thoracic Surgery; 🇭🇺 Budapest, Hungary