Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer: RCT

Summary

During video-assisted thoracoscopic lobectomy (VATS), the surgeon inserts a small camera attached to a thoracoscope that puts the image onto a video screen. Instruments are inserted via small incisions, and the lung resection is completed. Robotic thoracic surgery (RTS) uses a similar minimally invasive approach, but the very precise instruments involved with RTS allow the surgeon to view the lung using 3-dimensional imaging. The instruments give the surgeons increased range of motion during the surgery, and research demonstrates that RTS has a less steep learning curve as compared to VATS. Both VATS and RTS demonstrated better results as compared to traditional thoracotomy (open surgery). However, Robotic lobectomy has not yet been compared directly to video-assisted thoracoscopic lobectomy (VATS) in a prospective manner.

There are two major barriers against the widespread adoption of robotic thoracic surgery. The first barrier is the lack of high-quality prospective data. To our knowledge, there are no prospective trials comparing VATS to RTS for early stage lung cancer. The second major barrier to the widespread adoption of robotic technology in thoracic surgery is the perceived higher cost of Robotic lobectomy. To address these barriers, the investigators will undertake the first randomized controlled trial comparing Thoracoscopic Lobectomy to Robotic Lobectomy for early stage lung cancer.

Prospective randomization will eliminate the biases of retrospective data and will serve to determine whether there exist any advantages to Health Related Quality of life (HRQOL) or patient outcomes in favour of Robotic Lobectomy over VATS Lobectomy. Furthermore, through a prospective cost-utility analysis, this trial will provide the highest quality data to evaluate the true economic impact of robotic technology in thoracic surgery in a Canadian health system.

Conditions

• Non-small Cell Lung Cancer
• Thoracic Surgery

Interventions

PROCEDURE

Video-assisted thoracoscopic surgery

patients randomized to this arm will receive video-assisted thoracic surgery (VATS)

PROCEDURE

Robotic thoracic surgery

patients randomized to this arm will receive robotic thoracic surgery (RTS) with the da Vinci Robot

Sponsors & Collaborators

• University of Toronto / Toronto General Hospital

  collaborator UNKNOWN

• University of Florida

  collaborator OTHER

• University Hospital, Rouen

  collaborator OTHER

• St Vincent's Hospital Melbourne

  collaborator OTHER

• University of Melbourne / St. Vincent's Private Hospital (Fitzroy, Australia)

  collaborator UNKNOWN

• University of Melbourne / Barwon Health (Geelong, Australia)

  collaborator UNKNOWN

• St. Joseph's Healthcare Hamilton

  lead OTHER

Principal Investigators

• Waël C Hanna, MDCM, MBA, FRCSC · McMaster University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2021-09-30

Completion

2031-09-30

Countries

• Canada

Study Locations