Comparing Outcomes for Minimally Invasive Techniques for Anatomic Lung Resection for Cancer - A Prospective, Comparative, Non-randomized, Open Label Post-market Observational Cohort Study Within Europe
Overview
- Phase
- Not Applicable
- Intervention
- Robotic Assisted Thoracic Surgery
- Conditions
- Lung Cancer
- Sponsor
- Intuitive Surgical
- Enrollment
- 512
- Locations
- 13
- Primary Endpoint
- Patient reported Quality of Life 2
- Status
- Recruiting
- Last Updated
- 26 days ago
Overview
Brief Summary
To compare outcomes of minimally invasive surgical techniques for the treatment of early-stage non-small cell lung cancer.
Detailed Description
Detection of lung cancer is occurring at increasingly earlier stages due to improved screening and the discovery of incidental nodules. Coinciding with this trend is recent data from two international randomized, control trials, RAVAL - (Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer) and, JCOG0802 (The Japan Clinical Oncology Group) that show oncologic outcomes from segmentectomy are equivalent to lobectomy for cancers ≤2 cm. However, segmentectomy is a more complex technical operation that may not be easily feasible using video assisted thoracic surgery (VATS) but could be facilitated by robotic-assisted thoracic surgery (RATS), allowing improved vision, precision and controlled anatomic dissection. The LARCS study is designed to understand the perioperative outcomes of patients and identify the real-world selection process of either VATS and RATS segmentectomy and lobectomy for lung cancers ≤2 cm. It aims to generate evidence to support integration of patient-centered care using minimally invasive technology. In addition, health related quality of life captured in the study will also provide valuable insight into time to recovery, determining burden of the disease, and guide future treatment strategy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient diagnosed with clinical stage IA1-2 non-small cell lung cancer at time of procedure
- •Patient scheduled to undergo minimally invasive surgery for NSCLC with either da Vinci robotic assisted surgery or VATs
- •Aged ≥ 18 years
- •Must be willing and able to comply with study requirements
- •Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form
Exclusion Criteria
- •Patients with clinical stage IA3, II, III, and IV lung cancer
- •Patient receiving a lobectomy/segmentectomy as an emergency procedure
- •Patients receiving a lobectomy/segmentectomy for metastatic cancer
- •Patients scheduled to receive a bilobectomy or sleeve-lobectomy
- •Mental incapacity to understand or consent to study procedures
- •Anticipated difficulty for patient to comply with protocol requirements
- •Unable to comply with the follow up schedule
- •Pregnant or are planning to become pregnant during the study
- •Life expectancy \< 12 months
Arms & Interventions
Robotic Assisted Thoracic Surgery
Participants will undergo robotic assisted thoracic surgery (RATS) for segmentectomy or lobectomy.
Intervention: Robotic Assisted Thoracic Surgery
Video Assisted Thoracic Surgery
Participants will undergo video assisted thoracic surgery (VATS) for segmentectomy or lobectomy.
Intervention: Video Assisted Thoracic Surgery
Outcomes
Primary Outcomes
Patient reported Quality of Life 2
Time Frame: 1 month post surgery
RNLI (Reintegration to Normal Living Index) The RNLI has 11 questions and is scored on a visual analogue scale (VAS). On one end: "does not describe my situation" (1 or minimal integration) and "fully describes my situation" (10 or complete integration). Individual item scores are summed to provide the total score. The higher the score, the better the patients perceived integration.
Patient reported Quality of Life 1
Time Frame: 1 month post surgery
EQ 5D 5L (European Quality of Life Five Dimension) The EQ-5D-5L is a validated and established generic Patient Reported Outcome (PRO) instrument that uses 6 questions to assess patients' quality of life. It includes a vertical EQ visual analog scale (EQ VAS, 0-100 points) and a descriptive EQ-5D-5L system. An algorithm is used to calculate the scores. For the descriptive section of the scale, an index value of 1 represents the best possible health state, while an index value of \<0 (variable) represents the worst possible health state. The EQ VAS score is rated on a scale of 0-100 points. 0 points correspond to the worst possible health status, while 100 points correspond to the best possible health status.
Secondary Outcomes
- Number of conversions from pre-operative surgical plan(immediately post operative)