Actively Recruiting
A Prospective, Single-center, Non-inferiority Clinical Trial Evaluating 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating methods to assist surgeons in accurately locating small lung nodules during thoracoscopic surgery. With increased detection of pulmonary nodules by low-dose spiral CT scans, surgical removal is preferred. The study compares two techniques for marking these nodules before surgery: one using a bronchoscopic navigation robot and the other using an electromagnetic navigation system. The goal is to determine if the robot-guided method is as successful as the electromagnetic system and to explore potential benefits like easier operation and shorter surgery times. Participants will be randomly assigned to one of two groups. In the experimental group, surgeons use a bronchoscopic navigation robot guided by a 3D lung image from preoperative CT scans to inject a dye marker near the nodule. In the control group, a conventional electromagnetic navigation bronchoscope guides dye injection based on a virtual bronchial map. After dye marking, all patients undergo video-assisted thoracoscopic surgery to remove the nodules, starting with sub-lobar resection and possibly extending based on intraoperative findings. During the study, researchers will assess how often the dye marking successfully locates the nodules, the need for additional tissue removal, surgery duration, hospital stay length, and any complications from the dye marking. Participants will be monitored throughout their hospital stay, which can last from 1 to 30 days. The study is conducted at a single center and aims to provide a new, efficient, and safe method for pulmonary nodule localization.
CONDITIONS
Brief 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
- Peripheral pulmonary nodules planned for single lesion non-anatomical sublobar resection via thoracoscopy after preoperative discussion
- Pulmonary nodules cannot be localized by visual inspection or palpation
- Able to understand the trial, comply with exams and follow-ups, and sign informed consent voluntarily
You will not qualify if you...
- Surgical contraindications meeting major or multiple minor criteria (e.g., FEV1 or DLCO ≤ 50%, age ≥ 75, pulmonary hypertension > 40 mmHg, LVEF ≤ 40%, low oxygen levels with high CO2)
- Contraindications for bronchoscopy such as active massive hemoptysis, recent heart attack or unstable angina, severe hypertension or arrhythmias, uncorrectable bleeding disorders, severe superior vena cava syndrome, suspected aortic aneurysm, multiple lung bullae, or very poor overall condition
- Breastfeeding, pregnant, or trying to conceive women
- Having electromagnetic active implantable devices
- Allergy to indocyanine green, anesthetics, or history of severe allergies
- Participation in drug trials within 3 months or other device trials within 30 days
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day for the surgical procedure
Participants undergo bronchoscopic navigation robot-guided or conventional electromagnetic navigation bronchoscope-assisted dye marking followed by thoracoscopic pulmonary nodule resection.
1 visit (in-person) for the procedure
Duration - Up to 30 days
Participants are monitored daily during their hospital stay for up to 30 days to assess recovery, complications, and length of hospital stay.
Daily visits during hospitalization
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
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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