Robot-assisted dye marking for lung nodule surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of bronchoscopic navigation robot-guided dye marking in assisting thoracoscopic resection of pulmonary nodules. Participants with lung nodules detected by CT scans will be randomly assigned to receive either robot-assisted staining localization or conventional electromagnetic navigation guidance. The primary goal is to compare the success rates of these two localization methods during surgery. This approach aims to enhance surgical precision and optimize patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged 18-80 years, regardless of gender;
* Peripheral pulmonary nodules, planned for single lesion non-anatomical sublobar resection via thoracoscopic assistance after preoperative discussion;
* Preoperative assessment indicates that the pulmonary nodules cannot be localized through visual inspection or palpation;
* Patients are able to understand the purpose of the trial, have good compliance with examinations and follow-ups, and voluntarily participate in the clinical trial by signing an informed consent form.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from this study:

\- Surgical contraindications that do not meet surgical tolerance standards: fulfilling one major criterion and/or two or more minor criteria.

Major criterion: Forced expiratory volume in 1 second (FEV1) or carbon monoxide diffusion capacity (DLCO) ≤ 50%.

Minor criterion: (1) FEV1 or DLCO 51%-60%; (2) Age ≥ 75 years; (3) Pulmonary hypertension \> 40 mmHg (1 mmHg = 0.133 kPa); (4) Left ventricular ejection fraction (LVEF) ≤ 40%; (5) Arterial blood partial pressure of oxygen (PaO2) \< 55 mmHg or arterial blood oxygen saturation (SpO2) ≤ 88% with arterial blood partial pressure of carbon dioxide (PaCO2) \> 45 mmHg.

* Contraindications for bronchoscopy, including: active massive hemoptysis; recent myocardial infarction or unstable angina; severe hypertension and arrhythmias; uncorrectable bleeding tendencies (such as severe coagulopathy, uremia, and severe pulmonary hypertension, etc.); severe superior vena cava syndrome; suspected aortic aneurysm; multiple pulmonary bullae; extremely poor overall condition;
* Female patients who are breastfeeding, pregnant, or trying to conceive;
* Patients with electromagnetic active implantable devices;
* Participants allergic to indocyanine green or anesthetics; or with a history of multiple severe allergies or hereditary allergies;
* Participation in drug clinical trials in the past 3 months, or currently participating, or participation in other medical device clinical trials within the past 30 days;
* Other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Where it's running

• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Hecheng Li
• Email: lihecheng2000@hotmail.com
• Phone: 021-021-64370045

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.