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क्लिनिकल ट्रायल NCT06524427 (RAVAR) के लिए गैर-छोटे सेल फेफड़े का कैंसर वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें।
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Robot-Assisted vs. Video-Assisted Lobectomy for NSCLC (RAVAR) 1,124 रैंडमाइज़्ड अल्पकालिक

भर्ती जारी
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT06524427 (RAVAR) एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो गैर-छोटे सेल फेफड़े का कैंसर से जुड़ा हुआ है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 25 अगस्त 2020 को हुई थी, और इसमें कुल 1,124 प्रतिभागियों के नामांकन की योजना है। सन यात-सेन विश्वविद्यालय इस परीक्षण का नेतृत्व कर रहे हैं और इसके 31 दिसंबर 2030 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 31 दिसंबर 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
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 unsolve...और दिखाएँ
आधिकारिक शीर्षक

Robot-Assisted Versus Video-Assisted Lobectomy for Non-Small Cell Lung Cancer (RAVAR): A Multicenter, Open-Label, Randomized, Non-Inferiority Trial

स्वास्थ्य स्थितियां
गैर-छोटे सेल फेफड़े का कैंसर
अन्य अध्ययन आईडी
  • RAVAR
  • SL-5010-2019-04
  • ChiCTR2000034737 (रजिस्ट्री पहचानकर्ता) (Chinese Clinical Trial Registry)
NCT नंबर
NCT06524427
अध्ययन प्रारंभ तिथि (वास्तविक)
2020-08-25
अंतिम अद्यतन प्रकाशित
2025-12-31
अध्ययन की समाप्ति तिथि (अनुमानित)
2030-12-31
नामांकन (अनुमानित)
1,124
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
भर्ती जारी
प्रमुख शब्द
Non-small cell lung cancer
Robotic-assisted lobectomy
Video-assisted lobectomy
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
प्रतिभागी समूह/शाखाहस्तक्षेप/उपचार
प्रयोगात्मकRATS group
Patients will receive robot-assisted lobectomy
Robot-assisted lobectomy
Patients will receive robot-assisted lobectomy using Da Vinci surgical system
सक्रिय तुलना समूहVATS group
Patients will receive video-assisted lobectomy
Video-assisted lobectomy
Patients will receive video-assisted lobectomy
प्राथमिक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
5-year disease-free survival (DFS)
Difference of 5-year disease free survival rate between the two groups
5 years after surgery
द्वितीयक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
5-year overall survival (OS)
Difference of 5-year overall survival rate between the two groups
5 years after surgery
3-year disease-free survival (DFS)
Difference of 3-year disease free survival rate between the two groups
3 years after surgery
3-year overall survival (OS)
Difference of 3-year overall survival rate between the two groups
3 years after surgery
Blood loss
Blood loss during the surgery
During the surgery
Conversion rate
The number of patients converted to thoracotomy divided by the total number of included patients in a group
During the surgery
Perioperative complication
Intraoperative and postoperative complications
The day of surgery, 2/4/8/12/26/52 weeks after surgery
Operative death rate
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
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
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
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
Operative time
The total time from skin to skin and the time of each step were recorded
During the surgery
The number of resected lymph nodes
The number of resected lymph nodes were calculated according to the official pathological report after surgery
Postoperative in-hospital stay up to 30 days
Chest tube duration
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
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
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
भागीदारी सहायक
पात्रता मानदंड

अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
  1. Age from 18 to 80 years old;
  2. 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;
  3. The first clinical diagnosis before surgery was non-small cell lung cancer, including adenocarcinoma, squamous cell carcinoma, large cell carcinoma, and other unknown types;
  4. Clinical stage T1-2N0-1 (cI-II): Maximum diameter of tumor <= 5cm and short diameter of mediastinal lymph node <= 1cm in thin layer CT;
  5. Performance status of Eastern Cooperative Oncology Group (ECOG) 0-1;
  6. All relevant examinations were completed within 28 days before the operation;
  7. Patients who understand this study and have signed an approved Informed Consent.

  1. Patients with radiotherapy, chemotherapy, targeted therapy, or immunotherapy before surgery.
  2. Patients with the previous history of other malignancies;
  3. Patients with secondary primary cancer when enrolled;
  4. Patients diagnosed as pure ground glass opacity (GGO) before surgery;
  5. Patients diagnosed as mixed GGO whose solid part <= 50% and Maximum diameter of tumor <= 2cm;
  6. Patients with small cell lung cancer;
  7. Patients with prior unilateral open thoracic surgical procedures;
  8. Woman who is pregnant or breastfeeding;
  9. Patients with interstitial pneumonia, pulmonary fibrosis, or severe emphysema;
  10. Patients with an active bacterial or fungal infection that is difficult to control;
  11. Patients with serious psychosis;
  12. Patients with a history of severe heart attack, heart failure, myocardial infarction, or angina within the last 6 months.
Sun Yat-sen University logoसन यात-सेन विश्वविद्यालय1239 सक्रिय क्लिनिकल ट्रायल्स खोजे जाने के लिए
अध्ययन उत्तरदायी पक्ष
Hao-Xian Yang, मुख्य अन्वेषक, Principal Investigator, Sun Yat-sen University
अध्ययन केंद्रीय संपर्क
संपर्क: Hao-Xian Yang, M.D., +86-020-87343628, [email protected]
संपर्क: Mu-Zi Yang, M.D., +86-020-87341456, [email protected]
23 1 देशों में अध्ययन स्थान

Chongqing Municipality

First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, 400014, China
Ming Du, M.D., संपर्क, [email protected]
भर्ती जारी

Gansu

Gansu Provincial Hospital, Lanzhou, Gansu, 730000, China
Yun-Jiu Gou, M.D., संपर्क, [email protected]
भर्ती जारी
The Second Hospital of Lanzhou University, Lanzhou, Gansu, 730030, China
Bin Li, M.D., संपर्क, [email protected]
भर्ती जारी

Guangdong

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China
Hao-Xian Yang, M.D., संपर्क, +86-020-87343628, [email protected]
Mu-Zi Yang, M.D., संपर्क, +86-020-87341456, [email protected]
Hao-Xian Yang, M.D., मुख्य अन्वेषक
भर्ती जारी
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, 510080, China
Gui-Bin Qiao, M.D., संपर्क, [email protected]
भर्ती जारी
Shenzhen People's Hospital, Shenzhen, Guangdong, 518020, China
Guang-Suo Wang, M.D., संपर्क, [email protected]
भर्ती जारी
Shenzhen Third People's Hospital, Shenzhen, Guangdong, 518112, China
Kun Qiao, M.D., संपर्क, [email protected]
भर्ती जारी

Guangxi

Guangxi Nanxishan Hospital, Guilin, Guangxi, 541002, China
Rong-Sheng Xiong, M.D., संपर्क, [email protected]
भर्ती जारी

Henan

The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China
Yu Qi, M.D., संपर्क, [email protected]
भर्ती जारी

Hubei

Wuhan Union Hospital, Wuhan, Hubei, 430022, China
Yong-De Liao, M.D., संपर्क, [email protected]
भर्ती जारी
Wuhan TongJi Hospital, Wuhan, Hubei, 430030, China
Ni Zhang, M.D., संपर्क, [email protected]
भर्ती जारी

Jiangsu

The General Hospital of Eastern Theater Command, Nanjing, Jiangsu, 210002, China
Jun Yi, M.D., संपर्क, [email protected]
भर्ती जारी
Jiangsu Cancer Institute & Hospital, Nanjing, Jiangsu, 210009, China
Ming Li, M.D., संपर्क, [email protected]
भर्ती जारी

Jiangxi

Jiangxi Provincial People's Hopital, Nanchang, Jiangxi, 330006, China
Quan Xu, M.D., संपर्क, [email protected]
भर्ती जारी
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006, China
Ben-Tong Yu, M.D., संपर्क, [email protected]
भर्ती जारी

Liaoning

Liaoning Tumor Hospital & Institute, Shenyang, Liaoning, 110042, China
Hong-Xu Liu, M.D., संपर्क, [email protected]
भर्ती जारी

Shaanxi

Tang-Du Hospital, Xi'an, Shaanxi, 710038, China
Xiao-Long Yan, M.D., संपर्क, [email protected]
भर्ती जारी

Shandong

Qilu Hospital of Shandong University, Jinan, Shandong, 250012, China
Wei-Ming Yue, M.D., संपर्क, [email protected]
भर्ती जारी
Qianfoshan Hospital, Jinan, Shandong, 250014, China
Hui Tian, M.D., संपर्क, [email protected]
भर्ती जारी
Shandong Provincial Hospital, Jinan, Shandong, 250022, China
Zhong-Min Peng, M.D., संपर्क, [email protected]
भर्ती जारी
The Affiliated Hospital of Qingdao University, Qingdao, Shandong, 266003, China
Wen-Jie Jiao, M.D., संपर्क, [email protected]
भर्ती जारी

Sichuan

Sichuan Cancer Hospital and Research Institute, Chengdu, Sichuan, 610041, China
Bin Hu, M.D., संपर्क, [email protected]
भर्ती जारी
West China Hospital, Chengdu, Sichuan, 610041, China
Yun Wang, M.D., संपर्क, [email protected]
भर्ती जारी