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

Last updated: February 9, 2025
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pulmonary Nodules

Treatment

Bronchoscopic navigation robot

Conventional electromagnetic navigation bronchoscope

Clinical Study ID

NCT06821451
RTS-025
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 18-80 years, regardless of gender;

  • Peripheral pulmonary nodules, planned for single lesion non-anatomical sublobarresection via thoracoscopic assistance after preoperative discussion;

  • Preoperative assessment indicates that the pulmonary nodules cannot be localizedthrough visual inspection or palpation;

  • Patients are able to understand the purpose of the trial, have good compliance withexaminations and follow-ups, and voluntarily participate in the clinical trial bysigning an informed consent form.

Exclusion

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: fulfillingone 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; recentmyocardial infarction or unstable angina; severe hypertension and arrhythmias;uncorrectable bleeding tendencies (such as severe coagulopathy, uremia, and severepulmonary hypertension, etc.); severe superior vena cava syndrome; suspected aorticaneurysm; 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 ofmultiple severe allergies or hereditary allergies;

  • Participation in drug clinical trials in the past 3 months, or currentlyparticipating, or participation in other medical device clinical trials within thepast 30 days;

  • Other conditions deemed unsuitable for participation in this clinical trial by theinvestigator.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Bronchoscopic navigation robot
Phase:
Study Start date:
February 10, 2025
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

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