Roboticky asistovaná vs. video-asistovaná lobektomie pro NSCLC (RAVAR) (RAVAR)
Roboticky asistovaná versus video-asistovaná lobektomie pro nemalobuněčný karcinom plic (RAVAR): Multicentrická, otevřená, randomizovaná, non-inferioritní studie
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Čína, 400014
- First Affiliated Hospital of Chongqing Medical University
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Gansu
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Lanzhou, Gansu, Čína, 730030
- The Second Hospital of Lanzhou University
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Lanzhou, Gansu, Čína, 730000
- Gansu Provincial Hospital
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Guangdong
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Guangzhou, Guangdong, Čína, 510060
- Sun Yat-sen University Cancer Center
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Guangzhou, Guangdong, Čína, 510080
- Guangdong Provincial People's Hospital
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Shenzhen, Guangdong, Čína, 518020
- Shenzhen People's Hospital
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Shenzhen, Guangdong, Čína, 518112
- Shenzhen Third People's Hospital
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Guangxi
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Guilin, Guangxi, Čína, 541002
- Guangxi Nanxishan Hospital
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Henan
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Zhengzhou, Henan, Čína, 450052
- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, Čína, 430022
- Wuhan Union Hospital
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Wuhan, Hubei, Čína, 430030
- Wuhan TongJi Hospital
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Jiangsu
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Nanjing, Jiangsu, Čína, 210009
- Jiangsu Cancer Institute & Hospital
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Nanjing, Jiangsu, Čína, 210002
- The General Hospital of Eastern Theater Command
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Jiangxi
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Nanchang, Jiangxi, Čína, 330006
- The First Affiliated Hospital of Nanchang University
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Nanchang, Jiangxi, Čína, 330006
- Jiangxi Provincial People's Hopital
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Liaoning
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Shenyang, Liaoning, Čína, 110042
- Liaoning Tumor Hospital & Institute
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Shaanxi
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Xi'an, Shaanxi, Čína, 710038
- Tang-Du Hospital
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Shandong
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Jinan, Shandong, Čína, 250012
- Qilu Hospital of Shandong University
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Jinan, Shandong, Čína, 250014
- Qianfoshan Hospital
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Jinan, Shandong, Čína, 250022
- Shandong Provincial Hospital
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Qingdao, Shandong, Čína, 266003
- The Affiliated Hospital of Qingdao University
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Sichuan
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Chengdu, Sichuan, Čína, 610041
- West China Hospital
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Chengdu, Sichuan, Čína, 610041
- Sichuan Cancer Hospital and Research Institute
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: RATS group
Patients will receive robot-assisted lobectomy |
Patients will receive robot-assisted lobectomy using Da Vinci surgical system |
|
Aktivní komparátor: VATS group
Patients will receive video-assisted lobectomy |
Patients will receive video-assisted lobectomy |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
5-year disease-free survival (DFS)
Časové okno: 5 years after surgery
|
Difference of 5-year disease free survival rate between the two groups |
5 years after surgery
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
5-year overall survival (OS)
Časové okno: 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)
Časové okno: 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)
Časové okno: 3 years after surgery
|
Difference of 3-year overall survival rate between the two groups |
3 years after surgery
|
|
Blood loss
Časové okno: During the surgery
|
Blood loss during the surgery |
During the surgery
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Conversion rate
Časové okno: 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
Časové okno: 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
|
|
Operative death rate
Časové okno: 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
|
|
Hospital stays after surgery
Časové okno: 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
|
|
Pain score after surgery
Časové okno: 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
|
|
R0 rate
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
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Acesodyne (Grade III) dose
Časové okno: 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
|
|
Total cost of hospitalization
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Hao-Xian Yang, M.D., Sun Yat-Sen University Cancer Center
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SL-5010-2019-04
- ChiCTR2000034737 (Identifikátor registru: Chinese Clinical Trial Registry)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
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