Robot-Assisted vs. Video-Assisted Lobectomy for NSCLC (RAVAR)

Sun Yat-sen University1,124 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,124

Conditions

Non Small Cell Lung Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (23)

First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

Gansu Provincial Hospital

Lanzhou, Gansu, China

RECRUITING

The Second Hospital of Lanzhou University

Lanzhou, Gansu, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Shenzhen People's Hospital

Shenzhen, Guangdong, China

RECRUITING

Shenzhen Third People's Hospital

Shenzhen, Guangdong, China

RECRUITING

Guangxi Nanxishan Hospital

Guilin, Guangxi, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

Wuhan Union Hospital

Wuhan, Hubei, China

RECRUITING

...and 13 more locations

Outcomes

Primary Outcomes

5-year disease-free survival (DFS)

Difference of 5-year disease free survival rate between the two groups

Time frame: 5 years after surgery

Secondary Outcomes

5-year overall survival (OS)

Difference of 5-year overall survival rate between the two groups

Time frame: 5 years after surgery

3-year disease-free survival (DFS)

Difference of 3-year disease free survival rate between the two groups

Time frame: 3 years after surgery

3-year overall survival (OS)

Difference of 3-year overall survival rate between the two groups

Time frame: 3 years after surgery

Blood loss

Blood loss during the surgery

Time frame: During the surgery

Conversion rate

The number of patients converted to thoracotomy divided by the total number of included patients in a group

Time frame: During the surgery

Perioperative complication

Intraoperative and postoperative complications

Time frame: 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

Time frame: 30/90 days after surgery

Hospital stays after surgery

The length of stay in hospital after surgery

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: Postoperative in-hospital stay up to 30 days

Total cost of hospitalization

The total cost of the patient from admission to discharge

Time frame: From the date of admission to the date of discharge, assessed up to 30 days

Central Contacts

Hao-Xian Yang, M.D.

CONTACT

+86-020-87343628 yanghx@sysucc.org.cn

Mu-Zi Yang, M.D.

CONTACT

+86-020-87341456 yangmz@sysucc.org.cn