Actively Recruiting
Bronchoscopic Navigation Robot-guided Dye Marking-assisted Thoracoscopic Pulmonary Nodule Resection
Led by Ruijin Hospital · Updated on 2025-02-12
80
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
With the widespread use of low-dose spiral CT screening for the lungs, an increasing number of small nodules are being detected, and surgical resection is the preferred method for clinical intervention of pulmonary nodules. Staining localization can assist surgeons in accurately locating pulmonary nodules during surgery, achieving complete resection of the nodules while minimizing the resection area, thereby optimizing surgical outcomes. The study will include individuals with pulmonary nodules detected by CT scans who require color localization assistance for thoracoscopic pulmonary nodule resection, randomly divided into two groups: one group will receive bronchoscopic navigation-assisted staining localization, while the other group will receive staining localization guided by an electromagnetic navigation system. The primary outcome is to evaluate the success rate of staining localization between the two groups. This study aims to assess, through a prospective, single-center, randomized controlled clinical trial, whether the success rate of staining localization guided by bronchoscopic navigation robots (experimental group) is not lower than that of staining localization guided by the electromagnetic navigation system (control group), while potentially offering advantages such as a shorter learning curve, ease of operation, and reduced surgical time. This will provide a new efficient and safe method for the localization of pulmonary nodules clinically, greatly supporting accurate treatment of pulmonary nodules.
CONDITIONS
Official Title
Bronchoscopic Navigation Robot-guided Dye Marking-assisted Thoracoscopic Pulmonary Nodule Resection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-80 years, any gender
- Have peripheral pulmonary nodules planned for single lesion non-anatomical sublobar resection using thoracoscopic assistance
- Pulmonary nodules that cannot be detected by visual inspection or palpation before surgery
- Able to understand the study purpose, comply with tests and follow-up, and voluntarily sign informed consent
You will not qualify if you...
- Surgical contraindications including major or multiple minor criteria such as FEV1 or DLCO ≤ 50%, age ≥ 75 years, pulmonary hypertension > 40 mmHg, left ventricular ejection fraction ≤ 40%, or low oxygen levels with high carbon dioxide
- Contraindications for bronchoscopy such as active massive bleeding, recent heart attack or unstable angina, severe hypertension or arrhythmias, uncorrected bleeding disorders, severe vena cava syndrome, suspected aortic aneurysm, multiple lung bullae, or very poor health
- Female patients who are breastfeeding, pregnant, or trying to conceive
- Patients with active electromagnetic implant devices
- Allergies to indocyanine green, anesthetics, or history of severe or hereditary allergies
- Participation in drug trials within last 3 months or device trials within last 30 days
- Other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
H
Hecheng Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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