Non Small Cell Lung Cancer
Conditions
Keywords
Non-small cell lung cancer, Robotic-assisted lobectomy, Video-assisted lobectomy
Brief 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.
Interventions
PROCEDURERobot-assisted lobectomy
Patients will receive robot-assisted lobectomy using Da Vinci surgical system
PROCEDUREVideo-assisted lobectomy
Patients will receive video-assisted lobectomy
Sponsors
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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Shenzhen People's Hospital
The First Affiliated Hospital of Zhengzhou University
Shandong Provincial Hospital
Jiangsu Cancer Institute & Hospital
Guangdong Provincial People's Hospital
Liaoning Cancer Hospital & Institute
Qilu Hospital of Shandong University
Jiangxi Provincial People's Hopital
Sichuan Cancer Hospital and Research Institute
Lanzhou University Second Hospital
Shenzhen Third People's Hospital
Qianfoshan Hospital
Guangxi Nanxishan Hospital
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year disease-free survival (DFS) | 5 years after surgery | Difference of 5-year disease free survival rate between the two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease-free survival (DFS) | 3 years after surgery | Difference of 3-year disease free survival rate between the two groups |
| 3-year overall survival (OS) | 3 years after surgery | Difference of 3-year overall survival rate between the two groups |
| Blood loss | During the surgery | Blood loss during the surgery |
| Conversion rate | During the surgery | The number of patients converted to thoracotomy divided by the total number of included patients in a group |
| Perioperative complication | The day of surgery, 2/4/8/12/26/52 weeks after surgery | Intraoperative and postoperative complications |
| Operative death rate | 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 |
| Hospital stays after surgery | Between the date of surgery and the date of discharge, assessed up to 30 days | The length of stay in hospital after surgery |
| 5-year overall survival (OS) | 5 years after surgery | Difference of 5-year overall survival rate between the two groups |
| R0 rate | 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 |
| Operative time | During the surgery | The total time from skin to skin and the time of each step were recorded |
| The number of resected lymph nodes | Postoperative in-hospital stay up to 30 days | The number of resected lymph nodes were calculated according to the official pathological report after surgery |
| Chest tube duration | Postoperative in-hospital stay up to 30 days | The number of days between the date of surgery and the date of chest tube removal |
| Acesodyne (Grade III) dose | 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. |
| Total cost of hospitalization | 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 |
| Pain score after surgery | 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. |
Countries
China
Contacts
Primary ContactHao-Xian Yang, M.D.
Backup ContactMu-Zi Yang, M.D.
Outcome results
None listed