Clinical trial NCT03134534: Robot-assisted vs VATS Lobectomy for NSCLC
Official title: The Study of Robotic-assisted Thoracoscopic Lobectomy Versus Video-assisted Thoracoscopic Lobectomy for Non-small Cell Lung Cancer (RVlob)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Neoplasm
Keywords: lobectomy
robot-assisted thoracoscopic surgery
lung cancer
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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. -

Primary outcomes:
measure: 3-year overall survival (OS)
timeFrame: 3 year after surgery
measure: Lymph node counts
timeFrame: postoperative in-hospital stay up to 30 days
Secondary outcomes:
measure: 3-year disease-free survival (DFS)
timeFrame: 3 year after surgery
measure: 1-year overall survival (OS)
timeFrame: 1 year after surgery
measure: 1-year disease-free survival (DFS)
timeFrame: 1 year after surgery
measure: R0 rate
timeFrame: postoperative in-hospital stay up to 30 days
measure: margin state
timeFrame: postoperative in-hospital stay up to 30 days
measure: operative time
timeFrame: postoperative in-hospital stay up to 30 days
measure: blood loss
timeFrame: postoperative in-hospital stay up to 30 days
measure: conversion rate
timeFrame: postoperative in-hospital stay up to 30 days
measure: operative accident event
timeFrame: postoperative in-hospital stay up to 30 days
measure: 30-day mortality
timeFrame: postoperative in-hospital stay up to 30 days
measure: length of stay (LOS)
timeFrame: postoperative in-hospital stay up to 30 days
measure: postoperative complications
timeFrame: postoperative in-hospital stay up to 30 days
measure: quality of life (QOL) at 3 month
timeFrame: at 3 month after surgery
Other outcomes:
measure: total hospitalization expenditures
timeFrame: postoperative in-hospital stay up to 30 days
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai JiaoTong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: He-Cheng Li, doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.