Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03134534
Other study ID # RTS-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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. -

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05202249 - Effect of Muscle and Skin Fixation of Thoracic Drainage Tube on Postoperative Pain N/A
Completed NCT00128037 - Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors (JCOG 9806) Phase 2
Terminated NCT03827850 - FGFR Inhibitor in FGFR Dysregulated Cancer Phase 2
Not yet recruiting NCT05857995 - Precision Lung Cancer Survivorship Care Intervention N/A
Recruiting NCT05521789 - Erector Spinae Block for Thoracic Surgery Phase 4
Completed NCT02331056 - Could the Stroke Volume Variation Predict a Fluid Responsiveness in Thoracotomy? N/A
Recruiting NCT04447482 - ENB Vs. Conventional Bronchoscopy With Fluoroscopy for Safe and Effective Biopsy of Pulmonary Lesions N/A
Recruiting NCT03010033 - Effect of Pulmonary Rehabilitation on Perioperative Outcomes in Smoker Patients With Lung Cancer N/A
Recruiting NCT04309955 - Modified Versus Traditional Thoracic Drainage After Thoracoscopic Surgery N/A
Active, not recruiting NCT04945928 - Safety and Feasibility of Surgery After Conversion Therapy for Locally Advanced and Advanced NSCLC N/A
Recruiting NCT06412172 - The Natural History and Biological Study of Pulmonary Recurrent Respiratory Papillomatosis (pRRP)