Clinical trial NCT02804893: Videothoracoscopic (VATS) vs. Robotic Approach for Lobectomy or Anatomical Segmentectomy
Official title: Prospective, Randomized, Multicentric Study On Videothoracoscopic (Vats) Vs Robotic Approach For Lobectomy Or Anatomical Segmentectomy In Patients Affected By Early Lung Cancer (ROMAN)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: Lung cancer, video-assisted thoracoscopic surgery, robotic-assisted thoracoscopic surgery
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: Fondazione Umberto Veronesi
First posted: 2016-06-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: date of Surgery
measure: Postoperative complications: surgical complications, higher or equal grade II assessed by Clavien-Dindo scale, within 90 days
timeFrame: within 90 days
Secondary outcomes:
measure: Duration of surgery
timeFrame: date of Surgery
measure: Number of resected lymph nodes and upstaging
timeFrame: date of Surgery
measure: Proportion of patients who undergo complete resection during the procedure
timeFrame: date of Surgery
measure: Postoperative hospital stay
timeFrame: 2 weeks
measure: Postoperative pain: daily evaluation with visual numeric scale before and after surgery until discharge
timeFrame: 2 weeks, 6 months and 12 months
measure: Quality of life by EORTC QOL-C30
timeFrame: 2 weeks, 6 months and 12 months
measure: Duration of analgesic use after discharge and time to return to normal daily activity
timeFrame: within 90 days
measure: Postoperative respiratory function: FEV 1, PEF and CV
timeFrame: 6 month postoperatively
measure: Rate of local and distant recurrence and disease free survival
timeFrame: 24 months
measure: Patient's immune response: analysis of PCR, serum interleukins, lymphocytes subpopulations
timeFrame: before surgery, 2 hours after surgery and at 3rd and 14th postoperative day
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Thoracic surgery Division, Istituto Clinico Humanitas
state: Milan
Study officials:
References:
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