Robot-Assisted vs. Video-Assisted Lobectomy for NSCLC (RAVAR)
NCT Number: NCT06524427
Acronym: RAVAR
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Non Small Cell Lung Cancer
Interventions: PROCEDURE: Robot-assisted lobectomy|PROCEDURE: Video-assisted lobectomy
Sponsor: Sun Yat-sen University
Collaborators: The First Affiliated Hospital of Nanchang University|The Affiliated Hospital of Qingdao University|The General Hospital of Eastern Theater Command|Gansu Provincial Hospital|Tang-Du Hospital|Wuhan TongJi Hospital|First Affiliated Hospital of Chongqing Medical University|West China Hospital|Wuhan Union Hospital, China|Shenzhen People's Hospital|The First Affiliated Hospital of Zhengzhou University|Shandong Provincial Hospital|Jiangsu Cancer Institute & Hospital|Guangdong Provincial People's Hospital|Liaoning Tumor Hospital & Institute|Qilu Hospital of Shandong University|Jiangxi Provincial People's Hopital|Sichuan Cancer Hospital and Research Institute|The Second Hospital of Lanzhou University|Shenzhen Third People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1124
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-08-26
Completion Date: 2029-12-31
Locations: First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400014, China|Gansu Provincial Hospital, Lanzhou, Gansu, 730000, China|The Second Hospital of Lanzhou University, Lanzhou, Gansu, 730030, China|Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China|Guangdong Provincial People's Hospital, Guangzhou, Guangdong, 510080, China|Shenzhen People's Hospital, Shenzhen, Guangdong, 518020, China|Shenzhen Third People's Hospital, Shenzhen, Guangdong, 518112, China|The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China|Wuhan Union Hospital, Wuhan, Hubei, 430022, China|Wuhan TongJi Hospital, Wuhan, Hubei, 430030, China|The General Hospital of Eastern Theater Command, Nanjing, Jiangsu, 210002, China|Jiangsu Cancer Institute & Hospital, Nanjing, Jiangsu, 210009, China|Jiangxi Provincial People's Hopital, Nanchang, Jiangxi, 330006, China|The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006, China|Liaoning Tumor Hospital & Institute, Shenyang, Liaoning, 110042, China|Tang-Du Hospital, Xi'an, Shaanxi, 710038, China|Qilu Hospital of Shandong University, Jinan, Shandong, 250012, China|Shandong Provincial Hospital, Jinan, Shandong, 250022, China|The Affiliated Hospital of Qingdao University, Qingdao, Shandong, 266003, China|Sichuan Cancer Hospital and Research Institute, Chengdu, Sichuan, 610041, China|West China Hospital, Chengdu, Sichuan, 610041, China

Summary:
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.

Primary Outcome Measures: 5-year disease-free survival (DFS), Difference of 5-year disease free survival rate between the two groups, 5 years after surgery
Secondary Outcome Measures: 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