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

Официальное название

A Prospective, Single-center, Non-inferiority Clinical Trial Study Evaluating the Effectiveness and Safety of Bronchoscopic Navigation Robot (bronchial Navigation Positioning Device) Guided Dye Marking-assisted Thoracoscopic Pulmonary Nodule Resection

Обзор

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.

Вмешательства

• Устройство 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 determin
• Устройство 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 workin

Первичные конечные точки

• Success rate of staining localization [Срок оценки: During surgical procedure]

Вторичные конечные точки (4)

• Re-excision rate [Срок оценки: During surgical procedure]
• Surgery duration [Срок оценки: During surgical procedure]
• Length of hospital stay [Срок оценки: From hospital admission to discharge, assessed daily throughout the hospitalization period (expected range: 1 to 30 days)]
• Incidence of complications related to staining localization [Срок оценки: During surgical procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

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

Идентификаторы

NCT: NCT06821451 · RTS-025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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