Bronchoscopic Navigation Robot-guided Dye Marking-assisted Thoracoscopic Pulmonary Nodule Resection

Not Applicable

Recruiting

• Conditions: Lung Nodules

• Registration Number: NCT06821451
• Lead Sponsor: Ruijin Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-09
• Last Update Submitted: 2025-02-09
• Study Start: 2025-02-10
• Study First Posted: 2025-02-12
• Last Update Posted: 2025-02-12
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Success rate of staining localization	During surgical procedure	The success rate of staining localization is defined as the number of cases with successful staining divided by the total number of cases undergoing surgery (100%). Successful staining is defined as the staining marker being clearly visible during thoracoscopy, with the staining point being less than 1 centimeter away from the nodule on the pleural projection.

Secondary Outcome Measures

Name	Time	Method
Re-excision rate	During surgical procedure	The re-excision rate is defined as the number of patients requiring repeat surgery due to positive margins or inability to localize the nodule in the resected specimen, divided by the total number of patients undergoing surgery (100%).
Surgery duration	During surgical procedure	Surgery duration is defined as the time starting from the catheter's advancement through the tracheal tube or laryngeal mask to the carina until the completion of staining localization.
Incidence of complications related to staining localization	During surgical procedure
Length of hospital stay	From hospital admission to discharge, assessed daily throughout the hospitalization period (expected range: 1 to 30 days)	The length of hospital stay is defined as the time from patient admission to discharge.

Trial Locations

Locations (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China