Robot-assisted vs VATS Lobectomy for NSCLC

Study Overview
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Brief Summary
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Robot-assisted thoracoscopic surgery (RATS) was widely used in thoracic surgery, the surgical safety and feasibility of RATS lobectomy for NSCLC has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial, the purpose of this study is to determine whether RATS lobectomy would be as effective as VATS lobectomy on short-term and long-term outcomes.

Detailed Description
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Video-assisted thoracoscopic surgery (VATS) lobectomy is recommended for non small cell lung cancer (NSCLC) with surgical indications in China, its oncological long-term outcomes has been widely approved. As a new form of VATS, robot-assisted thoracoscopic surgery (RATS) was widely used in thoracic surgery, the 3D vision and flexible robot arm were helpful for surgeons to perform precise operations, and RATS was reported to bring extra benefits to patients. The surgical safety and feasibility of RATS lobectomy for NSCLC has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial. so we designed this randomized controlled trial to determine whether RATS lobectomy would be as effective as VATS lobectomy on short-term and long-term outcomes.

Official Title
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The Study of Robotic-assisted Thoracoscopic Lobectomy Versus Video-assisted Thoracoscopic Lobectomy for Non-small Cell Lung Cancer (RVlob)

Conditions
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Pulmonary Neoplasm

Intervention / Treatment
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* Procedure: VATS lobectomy
* Procedure: RATS lobectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: surgical indication for lobectomy; minimal invasive surgery; ASA (American Society of Anesthesiologists) stage: I-III; sign the informed consent. - Exclusion Criteria: benign tumor or nodule; present of other malignancy; preoperative chemotherapy, radiotherapy, targeted therapy. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: VATS group<br>Surgical procedure: VATS lobectomy | Procedure: VATS lobectomy<br>* a minimal invasive surgical types for NSCLC: VATS lobectomy<br>|
| Other: RATS group<br>Surgical procedure: RATS lobectomy | Procedure: RATS lobectomy<br>* a minimal invasive surgical types for NSCLC: RATS lobectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year overall survival (OS) | OS at 3 year after surgery | 3 year after surgery | 
| Lymph node counts | overall lymph node counts, number of stations dissected, and number of lymph nodes in each lymph node station | postoperative in-hospital stay up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease-free survival (DFS) | DFS at 3 year after surgery | 3 year after surgery | 
| 1-year overall survival (OS) | OS at 1 year after surgery | 1 year after surgery | 
| 1-year disease-free survival (DFS) | DFS at 1 year after surgery | 1 year after surgery | 
| R0 rate | R0 radical rate | postoperative in-hospital stay up to 30 days | 
| margin state | positive margin rate | postoperative in-hospital stay up to 30 days | 
| operative time | the time of operation | postoperative in-hospital stay up to 30 days | 
| blood loss | blood loss in the operation | postoperative in-hospital stay up to 30 days | 
| conversion rate | the rate of conversion to open surgery in the operation | postoperative in-hospital stay up to 30 days | 
| operative accident event | the accident event happened in operative | postoperative in-hospital stay up to 30 days | 
| 30-day mortality | 30-day mortality after surgery | postoperative in-hospital stay up to 30 days | 
| length of stay (LOS) | length of stay in hospitalization | postoperative in-hospital stay up to 30 days | 
| postoperative complications | mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula | postoperative in-hospital stay up to 30 days | 
| quality of life (QOL) at 3 month | QOL, WHOQOL-BREF | at 3 month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lobectomy, robot-assisted thoracoscopic surgery, lung cancer