Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 021, China
Completed
NCT Number: NCT03134534
Robot-assisted vs VATS Lobectomy for NSCLC
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.
Completed
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Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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. -
Treatment and study plan
VATS lobectomy
Procedurea minimal invasive surgical types for NSCLC: VATS lobectomy
RATS lobectomy
Procedurea minimal invasive surgical types for NSCLC: RATS lobectomy
Primary outcomes
-
3-year overall survival (OS)
Time frame: 3 year after surgery
OS at 3 year after surgery
-
Lymph node counts
Time frame: postoperative in-hospital stay up to 30 days
overall lymph node counts, number of stations dissected, and number of lymph nodes in each lymph node station
Secondary outcomes
-
3-year disease-free survival (DFS)
Time frame: 3 year after surgery
DFS at 3 year after surgery
-
1-year overall survival (OS)
Time frame: 1 year after surgery
OS at 1 year after surgery
-
1-year disease-free survival (DFS)
Time frame: 1 year after surgery
DFS at 1 year after surgery
-
R0 rate
Time frame: postoperative in-hospital stay up to 30 days
R0 radical rate
-
margin state
Time frame: postoperative in-hospital stay up to 30 days
positive margin rate
-
operative time
Time frame: postoperative in-hospital stay up to 30 days
the time of operation
-
blood loss
Time frame: postoperative in-hospital stay up to 30 days
blood loss in the operation
-
conversion rate
Time frame: postoperative in-hospital stay up to 30 days
the rate of conversion to open surgery in the operation
-
operative accident event
Time frame: postoperative in-hospital stay up to 30 days
the accident event happened in operative
-
30-day mortality
Time frame: postoperative in-hospital stay up to 30 days
30-day mortality after surgery
-
length of stay (LOS)
Time frame: postoperative in-hospital stay up to 30 days
length of stay in hospitalization
-
postoperative complications
Time frame: postoperative in-hospital stay up to 30 days
mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula
-
quality of life (QOL) at 3 month
Time frame: at 3 month after surgery
QOL, WHOQOL-BREF
Other outcomes
-
total hospitalization expenditures
Time frame: postoperative in-hospital stay up to 30 days
cost in hospital
Sponsors and collaborators
Lead sponsor
Ruijin Hospital
Other
Registry information
Official study title
The Study of Robotic-assisted Thoracoscopic Lobectomy Versus Video-assisted Thoracoscopic Lobectomy for Non-small Cell Lung Cancer (RVlob)
Acronym: RVlob
Important dates
- Study start
- 2017
- Primary completion
- 2023
- Study completion
- 2023
- First posted
- May 1, 2017
- Registry last updated
- Oct 31, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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