Robot-assisted vs VATS Lobectomy for NSCLC

Pulmonary Neoplasm Clinical Trial

— RVlob  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134534
• Other study ID #: RTS-002
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: May 31, 2023

Study information

• Verified date: October 2023
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. surgical indication for lobectomy;

2. minimal invasive surgery;

3. ASA (American Society of Anesthesiologists) stage: I-III;

4. sign the informed consent. -

Exclusion Criteria:

1. benign tumor or nodule;

2. present of other malignancy;

3. preoperative chemotherapy, radiotherapy, targeted therapy. -

Related Conditions & MeSH terms

• Lung Neoplasms
• Pulmonary Neoplasm

Intervention

Procedure:
• VATS lobectomy
a minimal invasive surgical types for NSCLC: VATS lobectomy
• RATS lobectomy
a minimal invasive surgical types for NSCLC: RATS lobectomy

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai JiaoTong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

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