Lobectomía asistida por robot versus lobectomía asistida por video para el NSCLC (RAVAR) (RAVAR)
Lobectomía asistida por robot versus lobectomía asistida por video para el cáncer de pulmón de células no pequeñas (RAVAR): un ensayo multicéntrico, abierto, aleatorizado y de no inferioridad
Video-assisted thoracic surgery (VATS) has been recommended by clinical guidelines as one of the preferred surgeries for early-stage non-small cell lung cancer (NSCLC) for many years. However, VATS has inherent drawbacks, so at the beginning of this century, robotic-assisted thoracoscopic surgery (RATS) was first applied for lung resection. In recent years, RATS has developed rapidly, but there are still many unsolved scientific problems in the field of RATS. Thus, a multicenter prospective randomized controlled trial was conducted with stage I-II NSCLC patients as the study subject and 5-year DFS as the primary endpoint to compare the short-term and long-term outcomes of RATS and VATS in the treatment of early-stage NSCLC.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Porcelana, 400014
- First Affiliated Hospital of Chongqing Medical University
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Gansu
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Lanzhou, Gansu, Porcelana, 730030
- The Second Hospital of Lanzhou University
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Lanzhou, Gansu, Porcelana, 730000
- Gansu Provincial Hospital
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510060
- Sun Yat-sen University Cancer Center
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Guangzhou, Guangdong, Porcelana, 510080
- Guangdong Provincial People's Hospital
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Shenzhen, Guangdong, Porcelana, 518020
- Shenzhen People's Hospital
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Shenzhen, Guangdong, Porcelana, 518112
- Shenzhen Third People's Hospital
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Guangxi
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Guilin, Guangxi, Porcelana, 541002
- Guangxi Nanxishan Hospital
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Henan
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Zhengzhou, Henan, Porcelana, 450052
- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, Porcelana, 430022
- Wuhan Union Hospital
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Wuhan, Hubei, Porcelana, 430030
- Wuhan TongJi Hospital
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Jiangsu
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Nanjing, Jiangsu, Porcelana, 210009
- Jiangsu Cancer Institute & Hospital
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Nanjing, Jiangsu, Porcelana, 210002
- The General Hospital of Eastern Theater Command
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Jiangxi
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Nanchang, Jiangxi, Porcelana, 330006
- The First Affiliated Hospital of Nanchang University
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Nanchang, Jiangxi, Porcelana, 330006
- Jiangxi Provincial People's Hopital
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Liaoning
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Shenyang, Liaoning, Porcelana, 110042
- Liaoning Tumor Hospital & Institute
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Shaanxi
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Xi'an, Shaanxi, Porcelana, 710038
- Tang-Du Hospital
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Shandong
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Jinan, Shandong, Porcelana, 250012
- Qilu Hospital of Shandong University
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Jinan, Shandong, Porcelana, 250014
- Qianfoshan Hospital
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Jinan, Shandong, Porcelana, 250022
- Shandong Provincial Hospital
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Qingdao, Shandong, Porcelana, 266003
- The Affiliated Hospital of Qingdao University
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Sichuan
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Chengdu, Sichuan, Porcelana, 610041
- West China Hospital
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Chengdu, Sichuan, Porcelana, 610041
- Sichuan Cancer Hospital and Research Institute
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age from 18 to 80 years old;
- Patients with blood pressure<160/100mmHg, 5.6<blood glucose<11.2mmol/L, major organs function normally: (1) Goldman index between grade 1 and 2; (2) Predicted forced expiratory volume in 1s (FEV1) >= 40 % and diffusing capacity of the lung for carbon monoxide (DLCO) >= 40 %; (3) total bilirubin <= 1.5 upper limit of normal; (4) Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) <= 2.5 upper limit of normal; (5) creatinine <= 1.25 upper limit of normal and creatinine clearance rate (CCr) >= 60ml/min;
- The first clinical diagnosis before surgery was non-small cell lung cancer, including adenocarcinoma, squamous cell carcinoma, large cell carcinoma, and other unknown types;
- Clinical stage T1-2N0-1 (cI-II): Maximum diameter of tumor <= 5cm and short diameter of mediastinal lymph node <= 1cm in thin layer CT;
- Performance status of Eastern Cooperative Oncology Group (ECOG) 0-1;
- All relevant examinations were completed within 28 days before the operation;
- Patients who understand this study and have signed an approved Informed Consent.
Exclusion Criteria:
- Patients with radiotherapy, chemotherapy, targeted therapy, or immunotherapy before surgery.
- Patients with the previous history of other malignancies;
- Patients with secondary primary cancer when enrolled;
- Patients diagnosed as pure ground glass opacity (GGO) before surgery;
- Patients diagnosed as mixed GGO whose solid part <= 50% and Maximum diameter of tumor <= 2cm;
- Patients with small cell lung cancer;
- Patients with prior unilateral open thoracic surgical procedures;
- Woman who is pregnant or breastfeeding;
- Patients with interstitial pneumonia, pulmonary fibrosis, or severe emphysema;
- Patients with an active bacterial or fungal infection that is difficult to control;
- Patients with serious psychosis;
- Patients with a history of severe heart attack, heart failure, myocardial infarction, or angina within the last 6 months.
Plan de estudios
¿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 |
|---|---|
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Experimental: RATS group
Patients will receive robot-assisted lobectomy |
Patients will receive robot-assisted lobectomy using Da Vinci surgical system |
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Comparador activo: VATS group
Patients will receive video-assisted lobectomy |
Patients will receive video-assisted lobectomy |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
5-year disease-free survival (DFS)
Periodo de tiempo: 5 years after surgery
|
Difference of 5-year disease free survival rate between the two groups |
5 years after surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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5-year overall survival (OS)
Periodo de tiempo: 5 years after surgery
|
Difference of 5-year overall survival rate between the two groups |
5 years after surgery
|
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3-year disease-free survival (DFS)
Periodo de tiempo: 3 years after surgery
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Difference of 3-year disease free survival rate between the two groups |
3 years after surgery
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3-year overall survival (OS)
Periodo de tiempo: 3 years after surgery
|
Difference of 3-year overall survival rate between the two groups |
3 years after surgery
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Blood loss
Periodo de tiempo: During the surgery
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Blood loss during the surgery |
During the surgery
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Conversion rate
Periodo de tiempo: During the surgery
|
The number of patients converted to thoracotomy divided by the total number of included patients in a group |
During the surgery
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Perioperative complication
Periodo de tiempo: The day of surgery, 2/4/8/12/26/52 weeks after surgery
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Intraoperative and postoperative complications |
The day of surgery, 2/4/8/12/26/52 weeks after surgery
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Operative death rate
Periodo de tiempo: 30/90 days after surgery
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The number of patients died within 30/90 days after surgery divided by the total number of included patients in a group |
30/90 days after surgery
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Hospital stays after surgery
Periodo de tiempo: Between the date of surgery and the date of discharge, assessed up to 30 days
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The length of stay in hospital after surgery |
Between the date of surgery and the date of discharge, assessed up to 30 days
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Pain score after surgery
Periodo de tiempo: Scores were given daily after surgery and at weeks 2/4/8/12/26/52 after discharge
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The degree of pain after surgery was measured using Numerical Rating Scale (NRS). The patient is asked to make three pain ratings, corresponding to current, best and worst pain experienced over the past 24 hours on a scale of 0 (no pain) to 10 (worst pain imaginable). The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 hours. |
Scores were given daily after surgery and at weeks 2/4/8/12/26/52 after discharge
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R0 rate
Periodo de tiempo: Postoperative in-hospital stay up to 30 days
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The number of patients received R0 surgery divided by the total number of included patients in a group |
Postoperative in-hospital stay up to 30 days
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Operative time
Periodo de tiempo: During the surgery
|
The total time from skin to skin and the time of each step were recorded |
During the surgery
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The number of resected lymph nodes
Periodo de tiempo: Postoperative in-hospital stay up to 30 days
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The number of resected lymph nodes were calculated according to the official pathological report after surgery |
Postoperative in-hospital stay up to 30 days
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Chest tube duration
Periodo de tiempo: Postoperative in-hospital stay up to 30 days
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The number of days between the date of surgery and the date of chest tube removal |
Postoperative in-hospital stay up to 30 days
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Acesodyne (Grade III) dose
Periodo de tiempo: Postoperative in-hospital stay up to 30 days
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The total amount of morphine used by the patient during the postoperative hospital stay, including morphine, pethidine, and fentanyl etc. |
Postoperative in-hospital stay up to 30 days
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Total cost of hospitalization
Periodo de tiempo: From the date of admission to the date of discharge, assessed up to 30 days
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The total cost of the patient from admission to discharge |
From the date of admission to the date of discharge, assessed up to 30 days
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Hao-Xian Yang, M.D., Sun Yat-Sen University Cancer Center
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SL-5010-2019-04
- ChiCTR2000034737 (Identificador de registro: Chinese Clinical Trial Registry)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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