Robot-Assisted Versus Free-Hand CT-Guided Flexible Guidewire Localization of Pulmonary Nodules
A Prospective Randomized Controlled Study of Robot-Assisted Versus Conventional Free-Hand CT-Guided Preoperative Flexible Guidewire Localization of Pulmonary Nodules
Small pulmonary nodules can be difficult to identify during thoracoscopic surgery. CT-guided flexible guidewire localization helps surgeons locate these nodules before resection. This study compares robot-assisted and conventional free-hand localization at Peking University Third Hospital. Sixty adults who require preoperative localization will be randomly assigned to one of two groups, with 30 participants in each group. Both groups will use the same type of flexible guidewire localization needle. The primary objective is to compare radiation exposure measured by dose-length product. The study will also assess puncture performance, localization accuracy, procedure duration, CT scan count, and procedure-related complications.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
This investigator-initiated, prospective, single-center, randomized, parallel-group study compares robot-assisted and conventional free-hand CT-guided flexible guidewire localization before thoracoscopic pulmonary nodule resection. Written informed consent is obtained before enrollment.
Participants undergo a localization difficulty assessment. A computer-generated sequence assigns participants in a 1:1 ratio within low- and high-difficulty strata using block randomization. Both groups use the same type of flexible guidewire localization needle. In the robot-assisted group, CT images are used for three-dimensional reconstruction and trajectory planning. The physician confirms the target, entry point, angle, and depth, and inserts the needle with robotic trajectory guidance. Repeat CT confirms the needle position, and the guidewire is deployed after the planned target region has been reached. Post-localization CT assesses guidewire position and complications.
The procedure is open-label. The protocol specifies blinded assessment of post-localization CT images by two independent imaging physicians. Planned and actual puncture angles and depths, and the distance between the planned target and actual needle tip, are also recorded in the robot-assisted group. Conversion to free-hand localization is permitted when required for participant safety because of robotic system failure or failed registration, and the reason is recorded.
Continuous variables are summarized as means and standard deviations or medians and interquartile ranges, as appropriate. Between-group comparisons use the independent-samples t test or Mann-Whitney U test. Categorical variables are compared using the chi-square test or Fisher exact test.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Fuxin Guo
- Número de teléfono: +86 15269757106
- Correo electrónico: 15269757106@163.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100191
- Reclutamiento
- Peking University Third Hospital
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Contacto:
- Fuxin Guo
- Número de teléfono: +86 15269757106
- Correo electrónico: 15269757106@163.com
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age 18 to 80 years.
- A pulmonary nodule identified on preoperative high-resolution chest CT, with planned thoracoscopic wedge resection or segmentectomy.
- Maximum target nodule diameter of 20 mm or less.
- A pure ground-glass, part-solid (mixed ground-glass), or small solid nodule.
- A nodule considered difficult to identify by intraoperative inspection or palpation and requiring preoperative CT-guided localization.
- Ability to tolerate percutaneous pulmonary localization and subsequent video-assisted thoracoscopic surgery.
- Voluntary participation and written informed consent from the participant or a legally authorized representative.
Exclusion Criteria:
- Maximum target nodule diameter greater than 20 mm, or no need for preoperative localization in the investigator's judgment.
- No safe puncture trajectory that avoids major vessels, the heart, mediastinum, severe bullous disease, or other important structures.
- Severe pulmonary dysfunction that precludes percutaneous pulmonary puncture or thoracoscopic surgery.
- Coagulation dysfunction or inability to interrupt anticoagulant or antiplatelet treatment according to clinical standards.
- Clinically significant pneumothorax, pleural effusion, active infection, or another condition affecting safety assessment before localization.
- Pregnancy or breastfeeding.
- Inability to cooperate with positioning, breath-holding, or CT scanning.
- Severe ipsilateral pleural adhesions, previous thoracic surgery, or previous radiotherapy considered to compromise localization safety.
- Any other condition making participation unsuitable in the investigator's judgment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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Experimental: Robot-Assisted CT-Guided Localization
Participants undergo robot-assisted CT-guided flexible guidewire localization before thoracoscopic resection. The uInterv C550-A system is used for CT-based reconstruction and trajectory planning. The physician confirms the target, entry point, angle, and depth and inserts the needle with robotic trajectory guidance. CT confirms satisfactory needle-tip placement before guidewire deployment. Final CT assesses guidewire position and complications. Both arms use the same type of flexible guidewire localization needle. |
The uInterv C550-A robotic puncture navigation and positioning system is used for CT-guided preoperative flexible guidewire localization of pulmonary nodules. CT images are used for three-dimensional reconstruction and trajectory planning. The physician confirms the target, skin entry point, puncture angle, and depth, and inserts the needle with robotic trajectory guidance. CT confirms satisfactory needle-tip placement before the flexible guidewire is deployed. A final CT scan assesses guidewire position and procedure-related complications. The same type of flexible guidewire localization needle is used in both groups.
Otros nombres:
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Comparador activo: Conventional Free-Hand CT-Guided Localization
Participants undergo conventional free-hand CT-guided flexible guidewire localization before thoracoscopic resection. The physician selects the skin entry point and trajectory on CT images, inserts the localization needle under local anesthesia, and adjusts the needle as needed. CT confirms satisfactory needle-tip placement before guidewire deployment. Final CT assesses guidewire position and complications. Both arms use the same type of flexible guidewire localization needle. |
Percutaneous placement of a flexible guidewire localization needle using conventional manual trajectory planning and CT guidance before thoracoscopic resection. The physician inserts and adjusts the needle as needed. CT confirms satisfactory needle-tip placement before guidewire deployment, followed by final CT assessment. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Total Dose-Length Product
Periodo de tiempo: During the localization procedure, from the first CT scan to completion of the final CT scan after guidewire deployment
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Total dose-length product (DLP), measured in mGy·cm, summed across all localization-related CT acquisitions, including the initial planning CT, CT acquisitions during needle placement, and the final post-deployment CT. |
During the localization procedure, from the first CT scan to completion of the final CT scan after guidewire deployment
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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First-Attempt Puncture Success Rate
Periodo de tiempo: During the localization procedure
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Percentage of participants with satisfactory needle-tip placement on the first puncture attempt without subsequent needle adjustment. |
During the localization procedure
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Technical Localization Success Rate
Periodo de tiempo: From guidewire localization through completion of the subsequent thoracoscopic resection
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Percentage of participants in whom flexible guidewire localization enables intraoperative identification and resection of the target pulmonary nodule during thoracoscopic surgery. |
From guidewire localization through completion of the subsequent thoracoscopic resection
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Localization Deviation
Periodo de tiempo: During localization, on the CT scan confirming final needle-tip position before guidewire deployment
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Distance in millimeters between the planned target point and the actual needle-tip position, measured on CT after needle placement. |
During localization, on the CT scan confirming final needle-tip position before guidewire deployment
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Number of Needle Adjustments
Periodo de tiempo: During the localization procedure
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Number of adjustments to needle position after the initial needle insertion during CT-guided localization. |
During the localization procedure
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Number of Pleural Punctures
Periodo de tiempo: During the localization procedure
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Number of needle punctures through the pleura during CT-guided localization. |
During the localization procedure
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Localization Procedure Duration
Periodo de tiempo: During the localization procedure, from the first CT scan through completion of the final post-deployment CT scan
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Elapsed time in minutes from the start of the first localization-related CT scan to completion of the final CT scan after flexible guidewire deployment. |
During the localization procedure, from the first CT scan through completion of the final post-deployment CT scan
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Number of CT Acquisitions
Periodo de tiempo: During the localization procedure
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Total number of CT acquisitions performed for localization, including the initial planning CT, scans during needle placement, and the final CT after guidewire deployment. |
During the localization procedure
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Pneumothorax Rate
Periodo de tiempo: From localization through 2 months after localization
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Percentage of participants with localization-related pneumothorax, assessed on post-localization CT and during follow-up. |
From localization through 2 months after localization
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Intrapulmonary Hemorrhage Rate
Periodo de tiempo: From localization through 2 months after localization
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Percentage of participants with localization-related intrapulmonary hemorrhage, assessed on post-localization CT and during follow-up. |
From localization through 2 months after localization
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Guidewire Dislodgement or Migration Rate
Periodo de tiempo: From guidewire deployment through the subsequent thoracoscopic surgery; safety follow-up through 2 months after localization
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Percentage of participants with dislodgement or migration of the localization guidewire after deployment, assessed on CT and during subsequent thoracoscopic surgery. Events are recorded during the 2-month safety follow-up; the guidewire is used for preoperative localization and is not intended to remain in place throughout follow-up. |
From guidewire deployment through the subsequent thoracoscopic surgery; safety follow-up through 2 months after localization
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Fuxin Guo, Peking University Third Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
Otros números de identificación del estudio
- M20260645
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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