Робот-ассистированная и видео-ассистированная лобэктомия при НМРЛ (RAVAR) (RAVAR)
Робот-ассистированная и видео-ассистированная лобэктомия при немелкоклеточном раке легкого (RAVAR): многоцентровое открытое рандомизированное исследование не меньшей эффективности
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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Китай, 400014
- First Affiliated Hospital of Chongqing Medical University
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Gansu
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Lanzhou, Gansu, Китай, 730030
- The Second Hospital of Lanzhou University
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Lanzhou, Gansu, Китай, 730000
- Gansu Provincial Hospital
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Guangdong
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Guangzhou, Guangdong, Китай, 510060
- Sun Yat-sen University Cancer Center
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Guangzhou, Guangdong, Китай, 510080
- Guangdong Provincial People's Hospital
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Shenzhen, Guangdong, Китай, 518020
- Shenzhen People's Hospital
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Shenzhen, Guangdong, Китай, 518112
- Shenzhen Third People's Hospital
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Guangxi
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Guilin, Guangxi, Китай, 541002
- Guangxi Nanxishan Hospital
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Henan
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Zhengzhou, Henan, Китай, 450052
- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, Китай, 430022
- Wuhan Union Hospital
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Wuhan, Hubei, Китай, 430030
- Wuhan TongJi Hospital
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Jiangsu
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Nanjing, Jiangsu, Китай, 210009
- Jiangsu Cancer Institute & Hospital
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Nanjing, Jiangsu, Китай, 210002
- The General Hospital of Eastern Theater Command
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Jiangxi
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Nanchang, Jiangxi, Китай, 330006
- The First Affiliated Hospital of Nanchang University
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Nanchang, Jiangxi, Китай, 330006
- Jiangxi Provincial People's Hopital
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Liaoning
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Shenyang, Liaoning, Китай, 110042
- Liaoning Tumor Hospital & Institute
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Shaanxi
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Xi'an, Shaanxi, Китай, 710038
- Tang-Du Hospital
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Shandong
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Jinan, Shandong, Китай, 250012
- Qilu Hospital of Shandong University
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Jinan, Shandong, Китай, 250014
- Qianfoshan Hospital
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Jinan, Shandong, Китай, 250022
- Shandong Provincial Hospital
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Qingdao, Shandong, Китай, 266003
- The Affiliated Hospital of Qingdao University
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Sichuan
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Chengdu, Sichuan, Китай, 610041
- West China Hospital
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Chengdu, Sichuan, Китай, 610041
- Sichuan Cancer Hospital and Research Institute
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: RATS group
Patients will receive robot-assisted lobectomy |
Patients will receive robot-assisted lobectomy using Da Vinci surgical system |
|
Активный компаратор: VATS group
Patients will receive video-assisted lobectomy |
Patients will receive video-assisted lobectomy |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
5-year disease-free survival (DFS)
Временное ограничение: 5 years after surgery
|
Difference of 5-year disease free survival rate between the two groups |
5 years after surgery
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
5-year overall survival (OS)
Временное ограничение: 5 years after surgery
|
Difference of 5-year overall survival rate between the two groups |
5 years after surgery
|
|
3-year disease-free survival (DFS)
Временное ограничение: 3 years after surgery
|
Difference of 3-year disease free survival rate between the two groups |
3 years after surgery
|
|
3-year overall survival (OS)
Временное ограничение: 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
Временное ограничение: During the surgery
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Blood loss during the surgery |
During the surgery
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Conversion rate
Временное ограничение: During the surgery
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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
Временное ограничение: 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
Временное ограничение: 30/90 days after surgery
|
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
Временное ограничение: Between the date of surgery and the date of discharge, assessed up to 30 days
|
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
Временное ограничение: Scores were given daily after surgery and at weeks 2/4/8/12/26/52 after discharge
|
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
Временное ограничение: Postoperative in-hospital stay up to 30 days
|
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
Временное ограничение: During the surgery
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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
Временное ограничение: Postoperative in-hospital stay up to 30 days
|
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
Временное ограничение: Postoperative in-hospital stay up to 30 days
|
The number of days between the date of surgery and the date of chest tube removal |
Postoperative in-hospital stay up to 30 days
|
|
Acesodyne (Grade III) dose
Временное ограничение: Postoperative in-hospital stay up to 30 days
|
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
Временное ограничение: From the date of admission to the date of discharge, assessed up to 30 days
|
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
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Hao-Xian Yang, M.D., Sun Yat-Sen University Cancer Center
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- SL-5010-2019-04
- ChiCTR2000034737 (Идентификатор реестра: Chinese Clinical Trial Registry)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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