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

Not Applicable

Recruiting

• Conditions: Non-small Cell Lung Cancer; Thoracic Surgery
• Interventions: Procedure: Robotic thoracic surgery; Procedure: Video-assisted thoracoscopic surgery

• Registration Number: NCT02617186
• Lead Sponsor: St. Joseph's Healthcare Hamilton

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-22
• Study First Submitted QC: 2015-11-26
• Study First Posted: 2015-11-30
• Study Start: 2016-01
• Primary Completion: 2021-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-06
• Study Completion: 2031-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 592

Inclusion Criteria

1. Age >/= 18 years
2. Clinical stage I, II or IIIa non-small cell lung cancer (NSCLC)
3. Candidates for minimally invasive pulmonary lobectomy, as determined by the operating surgeon.

Exclusion Criteria

1. Clinical stage IIIb or IV NSCLC
2. Not a candidate for minimally invasive surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic Lobectomy	Robotic thoracic surgery	-
Thoracoscopic Lobectomy	Video-assisted thoracoscopic surgery	-

Primary Outcome Measures

Name	Time	Method
Difference in HRQOL scores at week 12 between the treatment groups	12 weeks post-surgery	Difference in HRQOL scores between the treatment groups, as measured by the EQ-5D-5L questionnaire at week 12.

Secondary Outcome Measures

Name	Time	Method
Resource utilization	1 year post-surgery	Costs associated with chronic post-surgical pain up to one year after surgery.
Short-term clinical outcome differences	3 weeks post-surgery	Post-surgical pain will be determined from the Numeric Pain Rating Scale
Difference in 5-year survival rate between the two groups	5 years post-surgery	Difference in 5-year survival rate between the two groups.
Cost Effectiveness	5 years post-surgery	The incremental cost per quality-adjusted life year (QALY) gained will be calculated to assess cost effectiveness.
Difference in HRQOL scores between the treatment groups	3, 7 weeks post-surgery; 6 months post-surgery; 1, 1.5, 2, 3, 4, 5 years post-surgery	Difference in HRQOL scores between the treatment groups, as measured by the EQ-5D-5L questionnaire at weeks 3 and 7; months 6, 12, 18, 24; and years 3, 4, and 5, which coincide with the intervals of oncological surveillance.

Trial Locations

Locations (1)

McMaster University / St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada