Clinical Evaluation of Vagal Nerve Preservation in Minimally Invasive Surgery for Early Lung Cancer (CEVNPIMISELC)
11 de octubre de 2019 actualizado por: Yongxin Zhou, Shanghai Tongji Hospital, Tongji University School of Medicine
Clinical Application of Vagus Nerve Preservation in Minimally Invasive Surgery for Early Lung Cancer
Through prospective, randomized and controlled clinical study, patients with early lung cancer who do not need lymph node dissection according to routine diagnosis and treatment were selected.
The feasibility and safety of preserving vagal pulmonary branch intact during minimally invasive surgery were compared with traditional minimally invasive surgery, and the feasibility and safety of preserving vagal pulmonary branch intact during minimally invasive surgery were clarified.
The effect of preserving pulmonary branches of vagus nerve in minimally invasive surgery of early lung cancer on preventing or reducing pulmonary complications after operation was evaluated by main observation indexes (incidence of pulmonary complications) and secondary evaluation indexes.
It will provide a safer, simpler and more effective new technology for patients with early lung cancer undergoing minimally invasive surgery, and provide a basis for the popularization of this new technology.
Descripción general del estudio
Estado
Desconocido
Condiciones
Descripción detallada
According to the suggestion of statistical experts and the minimum sample size, 120 IA1-2 patients who are going to undergo thoracoscopic lung surgery were selected according to the criteria of admission and exclusion.
The risk and benefit were informed and the informed consent of the subjects was signed.
The patients were numbered and randomly divided into two groups: group A with vagus nerve preservation during minimally invasive surgery and group B with traditional minimally invasive surgery for early lung cancer.
The incidence of pulmonary complications within 5 weeks after operation (see the evaluation criteria for details), operation time, intraoperative bleeding volume, postoperative drainage volume, postoperative mortality, incidence of cardiovascular complications, rate of re-tracheal intubation, rate of re-admission to ICU, duration of stay in ICU, hospitalization costs were observed.
Statistical analysis and evaluation of the safety of preserving pulmonary branches of vagus nerve in minimally invasive surgery and the effectiveness of preventing or reducing pulmonary complications after minimally invasive surgery.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
120
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Shanghai
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Shanghai, Shanghai, Porcelana, 200000
- Reclutamiento
- Yongxin Zhou
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Contacto:
- Wenli Wang, Master
- Número de teléfono: 13761295864
- Correo electrónico: Anderson840913@163.com
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Contacto:
- Shaorui Gu, scholor
- Número de teléfono: 18351977377
- Correo electrónico: 870005908@qq.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- (1) 18-70 years of age, regardless of gender;
- (2) From May 2019 to December 2021, patients with lung cancer who underwent thoracoscopic pneumonectomy (wedge-shaped, segment and lobe) were admitted to our hospital. Postoperative pathological diagnosis was non-small cell lung cancer. Preoperative pathological staging was T1a-bN0M0 and IA1-2 (pathological staging refers to UICC 8th Edition TNM staging standard for lung cancer).
- (3) In addition to routine examinations, all patients underwent enhanced chest CT, cranial CT/MRI, abdominal B-mode ultrasound, whole body bone isotope scan or PET-CT to exclude distant metastasis.
- (4) Subjects clearly understand the purpose of the study, are willing and able to comply with the requirements to complete the study, and sign the informed consent.
Exclusion Criteria:
- (1) Patients with other infectious diseases (inflammation, tuberculosis, etc.) in the thoracic cavity;
- (2) Patients are unwilling to accept the new technique of preserving pulmonary branch of vagus nerve during operation;
- (3) Clinical unstable patients with severe cardiovascular, renal and respiratory system;
- (4) Participated in other clinical trials within 30 days;
- (5) Other reasons why researchers think it is inappropriate to participate in the experiment.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Preservation of pulmonary vagus nerve
Preservation of pulmonary branches of vagus nerve in minimally invasive surgery for lung cancer
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In minimally invasive surgery for lung cancer, the experimental group retained the pulmonary branches of vagus nerve
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Experimental: No pulmonary vagus nerve preservation
In minimally invasive surgery for lung cancer, the pulmonary branches of vagus nerve were severed
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In minimally invasive surgery for lung cancer, the control group did not retain the vagus nerve.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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cough after pulmonary resection
Periodo de tiempo: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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(1) dry cough lasting no less than 2 weeks after pneumonectomy; (2) no obvious abnormalities in chest X-ray; (3) excluding drug factors such as postnasal drip syndrome, bronchial asthma and ACEI
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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pulmonary infection
Periodo de tiempo: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Postoperative pneumonia should be considered if there are three or more of the following indicators:
If it contains 4, only one of the other items can be considered as a respiratory consultation to determine pulmonary infection, and need to replace antibiotics or prolong the use of antibiotics. |
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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Atelectasis
Periodo de tiempo: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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(1) Imaging findings suggest atelectasis or consolidation of the lungs; (2) signs of dyspnea; (3) decreased oxygen saturation to below 90%.
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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hydrothorax
Periodo de tiempo: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Re-catheterization was needed; dyspnea symptoms; and drainage time was longer than 15 days.
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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Postoperative respiratory failure or ARDS or requiring tracheal intubation
Periodo de tiempo: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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Tracheal intubation; Ventilator; ICU
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Operation time;
Periodo de tiempo: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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Operation time;
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
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Intraoperative bleeding volume;
Periodo de tiempo: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Intraoperative bleeding volume;
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
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Postoperative drainage volume;
Periodo de tiempo: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Postoperative drainage volume;
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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Postoperative mortality
Periodo de tiempo: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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Postoperative mortality
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From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
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Postoperative cardiovascular complications
Periodo de tiempo: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Postoperative cardiovascular complications
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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Re-admission ICU rate;
Periodo de tiempo: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Re-admission ICU rate;
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From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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Time of stay in ICU;
Periodo de tiempo: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Time of stay in ICU;
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From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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Hospitalization days
Periodo de tiempo: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Hospitalization days
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
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Hospitalization expenses
Periodo de tiempo: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Hospitalization expenses
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Director de estudio: Yongxin zhou, Doctor, Tongji Hospital Affiliated to Tongji University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Chen W, Zheng R, Zeng H, Zhang S. Epidemiology of lung cancer in China. Thorac Cancer. 2015 Mar;6(2):209-15. doi: 10.1111/1759-7714.12169. Epub 2015 Mar 2.
- Sawabata N, Maeda H, Takeda S, Inoue M, Koma M, Tokunaga T, Matsuda H. Persistent cough following pulmonary resection: observational and empiric study of possible causes. Ann Thorac Surg. 2005 Jan;79(1):289-93. doi: 10.1016/j.athoracsur.2004.06.045.
- Sarna L, Evangelista L, Tashkin D, Padilla G, Holmes C, Brecht ML, Grannis F. Impact of respiratory symptoms and pulmonary function on quality of life of long-term survivors of non-small cell lung cancer. Chest. 2004 Feb;125(2):439-45. doi: 10.1378/chest.125.2.439.
- Weijs TJ, Goense L, van Rossum PSN, Meijer GJ, van Lier AL, Wessels FJ, Braat MN, Lips IM, Ruurda JP, Cuesta MA, van Hillegersberg R, Bleys RL. The peri-esophageal connective tissue layers and related compartments: visualization by histology and magnetic resonance imaging. J Anat. 2017 Feb;230(2):262-271. doi: 10.1111/joa.12552. Epub 2016 Sep 23.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2019
Finalización primaria (Anticipado)
30 de enero de 2021
Finalización del estudio (Anticipado)
31 de enero de 2022
Fechas de registro del estudio
Enviado por primera vez
5 de octubre de 2019
Primero enviado que cumplió con los criterios de control de calidad
11 de octubre de 2019
Publicado por primera vez (Actual)
14 de octubre de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de octubre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
11 de octubre de 2019
Última verificación
1 de octubre de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2019-LCYJ-006
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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