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

NCT ID: NCT06821451

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-10
• Study Completion Date: 2026-03-31

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.

Conditions

Lung Nodules

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Preoperative CT data creates a 3D image of the lung anatomy to plan the navigation path. The surgeon controls the robotic arm in real-time to reach staining marker points for pulmonary nodule localization. After placing the staining catheter in the working channel, 1 ml of indocyanine green is injected at the site. Then the patient is positioned laterally for video-assisted thoracoscopic surgery for nodule resection, initially focusing on sub-lobar resection. More extensive resection is determined based on intraoperative frozen section results.

Group Type: ACTIVE_COMPARATOR

Bronchoscopic navigation robot

Intervention Type: DEVICE

Preoperative CT data creates a 3D image of the lung anatomy to plan the navigation path. The surgeon controls the robotic arm in real-time to reach staining marker points for pulmonary nodule localization. After placing the staining catheter in the working channel, 1 ml of indocyanine green is injected at the site. Then the patient is positioned laterally for video-assisted thoracoscopic surgery for nodule resection, initially focusing on sub-lobar resection. More extensive resection is determined based on intraoperative frozen section results.

Control group

Based on preoperative CT data, a three-dimensional image of the virtual bronchi is created to plan the navigation path, and manual registration is completed by selecting registration points using a conventional bronchoscope. After registration, the target position is reached under the guidance of the magnetic navigation positioning system, and when the positioning sensor indicates that it has arrived at the staining marker point, a staining catheter is inserted through the working channel to inject 1 ml of indocyanine green at the marker site, followed by thoracoscopic resection of the pulmonary nodule.

Group Type: SHAM_COMPARATOR

Conventional electromagnetic navigation bronchoscope

Intervention Type: DEVICE

Based on preoperative CT data, a three-dimensional image of the virtual bronchi is created to plan the navigation path, and manual registration is completed by selecting registration points using a conventional electromagnetic bronchoscope. After registration, the target position is reached under the guidance of the magnetic navigation positioning system, and when the positioning sensor indicates that it has arrived at the staining marker point, a staining catheter is inserted through the working channel to inject 1 ml of indocyanine green at the marker site, followed by thoracoscopic resection of the pulmonary nodule.

Interventions

Bronchoscopic navigation robot

Preoperative CT data creates a 3D image of the lung anatomy to plan the navigation path. The surgeon controls the robotic arm in real-time to reach staining marker points for pulmonary nodule localization. After placing the staining catheter in the working channel, 1 ml of indocyanine green is injected at the site. Then the patient is positioned laterally for video-assisted thoracoscopic surgery for nodule resection, initially focusing on sub-lobar resection. More extensive resection is determined based on intraoperative frozen section results.

Intervention Type: DEVICE

Conventional electromagnetic navigation bronchoscope

Based on preoperative CT data, a three-dimensional image of the virtual bronchi is created to plan the navigation path, and manual registration is completed by selecting registration points using a conventional electromagnetic bronchoscope. After registration, the target position is reached under the guidance of the magnetic navigation positioning system, and when the positioning sensor indicates that it has arrived at the staining marker point, a staining catheter is inserted through the working channel to inject 1 ml of indocyanine green at the marker site, followed by thoracoscopic resection of the pulmonary nodule.

Intervention Type: DEVICE

Other Intervention Names

bronchoscopic navigation positioning device; Robotic-assisted bronchoscopy; robotic-assisted bronchoscopy system; ENB; Electromagnetic navigation bronchoscopy system

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hecheng Li M.D., Ph.D

Chair of Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hecheng Li

Role: CONTACT

lihecheng2000@hotmail.com

021-021-64370045

Facility Contacts

Hecheng Li

Role: primary

lihecheng2000@hotmail.com

86-021-64370045

Other Identifiers

RTS-025

Identifier Type: -

Identifier Source: org_study_id