Robot-assisted vs VATS Lobectomy for NSCLC (RVlob)

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Neoplasm
• Intervention / Treatment: Procedure: VATS lobectomy; Procedure: RATS lobectomy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 021
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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. -

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: VATS group; Surgical procedure: VATS lobectomy	Procedure: VATS lobectomy; a minimal invasive surgical types for NSCLC: VATS lobectomy
Other: RATS group; Surgical procedure: RATS lobectomy	Procedure: RATS lobectomy; a minimal invasive surgical types for NSCLC: RATS lobectomy

What is the study measuring?

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
30-day mortality	30-day mortality after surgery	postoperative in-hospital stay up to 30 days
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
3-year disease-free survival (DFS)	DFS at 3 year after surgery	3 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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
total hospitalization expenditures	cost in hospital	postoperative in-hospital stay up to 30 days

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: He-Cheng Li, doctor, Ruijin Hospital

Publications and helpful links

General Publications

• Jin R, Zheng Y, Yuan Y, Han D, Cao Y, Zhang Y, Li C, Xiang J, Zhang Z, Niu Z, Lerut T, Lin J, Abbas AE, Pardolesi A, Suda T, Amore D, Schraag S, Aigner C, Li J, Che J, Hang J, Ren J, Zhu L, Li H. Robotic-assisted Versus Video-assisted Thoracoscopic Lobectomy: Short-term Results of a Randomized Clinical Trial (RVlob Trial). Ann Surg. 2022 Feb 1;275(2):295-302. doi: 10.1097/SLA.0000000000004922.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: April 15, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 28, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: lung cancer; lobectomy; robot-assisted thoracoscopic surgery
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: RTS-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No