Robot-assisted dye marking for lung nodule surgery

A Prospective, Single-center, Non-inferiority Clinical Trial Study Evaluating the Effectiveness and Safety of Bronchoscopic Navigation Robot (bronchial Navigation Positioning Device) Guided Dye Marking-assisted Thoracoscopic Pulmonary Nodule Resection

This study tests if using a robot to help mark lung nodules before surgery works better than the usual method for people with lung nodules found on CT scans.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Ruijin Hospital (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06821451 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with peripheral pulmonary nodules that cannot be localized through visual inspection or palpation.

Not a fit: Patients with significant surgical contraindications or those who do not meet the specified health criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this method could improve the accuracy of lung nodule resections, leading to better surgical outcomes and reduced recovery times for patients.

How similar studies have performed: While similar approaches have been explored, this specific method of robot-assisted dye marking for lung nodule resection is relatively novel.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Hecheng Li

Conditions: Lung Nodules