Lung Cancer
Conditions
Keywords
Lung cancer, video-assisted thoracoscopic surgery, robotic-assisted thoracoscopic surgery
Brief summary
This is a prospective, randomized, multicenter study on 300 patients (150 VATS lobectomies and 150 robotic lobectomies) affected by early stage (I-II) lung cancer. The expected recruitment is one year and two year follow up. Surgeons should have a minimum of 30 major lung resections performed using one of the two techniques for participation in the study. Each participating centers should have the possibility to offer both techniques (Robotics and Vats). The primary end point is a combination of conversion and complication rate. The presence of at least one of the two events is considered a failure. Considering the rate of failure of 35% in the VATS arm, we want to see a failure rate not over 20% in the robot arm, so with a power of 80% and an alpha error of 5%, we need a total of 300 patients.
Interventions
PROCEDUREVATS
Thorax thoracoscopic surgery (lobectomy)
PROCEDURERATS
Thorax robotic surgery (lobectomy)
Sponsors
Fondazione Umberto Veronesi
Istituto Clinico Humanitas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age older than 18 years old * Known or suspected lung cancers * Patients in clinical stage T1-T2, N0-N1 candidate to surgery lobectomy or anatomical segmentectomy * ASA-1-2-3
Exclusion criteria
* Clinical stage \>II * Severe heart disease * Alcohol abuse * Renal impairment (creatinine \>2.5) * Presence of serious comorbidities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative complications: conversion rate, defined as procedures that start with minimally invasive access and are converted to open surgery due to different reasons (bleeding, anatomical reasons, oncological reasons, technical reasons, other) | date of Surgery |
| Postoperative complications: surgical complications, higher or equal grade II assessed by Clavien-Dindo scale, within 90 days | within 90 days |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who undergo complete resection during the procedure | date of Surgery |
| Postoperative hospital stay | 2 weeks |
| Postoperative pain: daily evaluation with visual numeric scale before and after surgery until discharge | 2 weeks, 6 months and 12 months |
| Quality of life by EORTC QOL-C30 | 2 weeks, 6 months and 12 months |
| Duration of surgery | date of Surgery |
| Postoperative respiratory function: FEV 1, PEF and CV | 6 month postoperatively |
| Rate of local and distant recurrence and disease free survival | 24 months |
| Patient's immune response: analysis of PCR, serum interleukins, lymphocytes subpopulations | before surgery, 2 hours after surgery and at 3rd and 14th postoperative day |
| Duration of analgesic use after discharge and time to return to normal daily activity | within 90 days |
| Number of resected lymph nodes and upstaging | date of Surgery |
Countries
Italy
Outcome results
None listed