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Robot-assisted vs VATS Lobectomy for NSCLC (RVlob)

Primary Purpose

Pulmonary Neoplasm

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
VATS lobectomy
RATS lobectomy
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Neoplasm focused on measuring lobectomy, robot-assisted thoracoscopic surgery, lung cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

  • Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

VATS group

RATS group

Arm Description

Surgical procedure: VATS lobectomy

Surgical procedure: RATS lobectomy

Outcomes

Primary Outcome Measures

3-year overall survival (OS)
OS at 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

Secondary Outcome Measures

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

Full Information

First Posted
April 15, 2017
Last Updated
August 29, 2021
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03134534
Brief Title
Robot-assisted vs VATS Lobectomy for NSCLC
Acronym
RVlob
Official Title
The Study of Robotic-assisted Thoracoscopic Surgery Versus Video-assisted Thoracoscopic Surgery Lobectomy for Non-small Cell Lung Cancer on Short-term and Long-term Outcomes (RVlob)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Neoplasm
Keywords
lobectomy, robot-assisted thoracoscopic surgery, lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VATS group
Arm Type
Other
Arm Description
Surgical procedure: VATS lobectomy
Arm Title
RATS group
Arm Type
Other
Arm Description
Surgical procedure: RATS lobectomy
Intervention Type
Procedure
Intervention Name(s)
VATS lobectomy
Intervention Description
a minimal invasive surgical types for NSCLC: VATS lobectomy
Intervention Type
Procedure
Intervention Name(s)
RATS lobectomy
Intervention Description
a minimal invasive surgical types for NSCLC: RATS lobectomy
Primary Outcome Measure Information:
Title
3-year overall survival (OS)
Description
OS at 3 year after surgery
Time Frame
3 year after surgery
Title
Lymph node counts
Description
overall lymph node counts, number of stations dissected, and number of lymph nodes in each lymph node station
Time Frame
postoperative in-hospital stay up to 30 days
Secondary Outcome Measure Information:
Title
3-year disease-free survival (DFS)
Description
DFS at 3 year after surgery
Time Frame
3 year after surgery
Title
1-year overall survival (OS)
Description
OS at 1 year after surgery
Time Frame
1 year after surgery
Title
1-year disease-free survival (DFS)
Description
DFS at 1 year after surgery
Time Frame
1 year after surgery
Title
R0 rate
Description
R0 radical rate
Time Frame
postoperative in-hospital stay up to 30 days
Title
margin state
Description
positive margin rate
Time Frame
postoperative in-hospital stay up to 30 days
Title
operative time
Description
the time of operation
Time Frame
postoperative in-hospital stay up to 30 days
Title
blood loss
Description
blood loss in the operation
Time Frame
postoperative in-hospital stay up to 30 days
Title
conversion rate
Description
the rate of conversion to open surgery in the operation
Time Frame
postoperative in-hospital stay up to 30 days
Title
operative accident event
Description
the accident event happened in operative
Time Frame
postoperative in-hospital stay up to 30 days
Title
30-day mortality
Description
30-day mortality after surgery
Time Frame
postoperative in-hospital stay up to 30 days
Title
length of stay (LOS)
Description
length of stay in hospitalization
Time Frame
postoperative in-hospital stay up to 30 days
Title
postoperative complications
Description
mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula
Time Frame
postoperative in-hospital stay up to 30 days
Title
quality of life (QOL) at 3 month
Description
QOL, WHOQOL-BREF
Time Frame
at 3 month after surgery
Other Pre-specified Outcome Measures:
Title
total hospitalization expenditures
Description
cost in hospital
Time Frame
postoperative in-hospital stay up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
He-Cheng Li, doctor
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
021
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33938492
Citation
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.
Results Reference
derived

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Robot-assisted vs VATS Lobectomy for NSCLC

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