CompletedNot Applicable

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

Hungary66 participantsStarted 2025-06-01

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time of Surgery

Timeframe: From the initiation of anesthesia to the completion of the surgery

Surgical Satisfaction Survey

Timeframe: From the completion of surgery within 24 hours

Trial details

NCT IDNCT06957600

SponsorSemmelweis University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-26

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