Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06038227

Lung cAncer Robotic Comparative Study

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
512 (estimated)
Sponsor
Intuitive Surgical · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURERobotic Assisted Thoracic SurgerySurgeons will pre-determine to perform a segmentectomy or lobectomy using RATS.
PROCEDUREVideo Assisted Thoracic SurgerySurgeons will pre-determine to perform a segmentectomy or lobectomy using VATS.

Timeline

Start date
2023-07-15
Primary completion
2027-12-30
Completion
2027-12-30
First posted
2023-09-14
Last updated
2026-04-06

Locations

12 sites across 6 countries: Denmark, France, Germany, Italy, Norway, United Kingdom

Source: ClinicalTrials.gov record NCT06038227. Inclusion in this directory is not an endorsement.