Videothoracoscopic (VATS) vs. Robotic Approach for Lobectomy or Anatomical Segmentectomy

Not Applicable

• Conditions: Lung Cancer
• Interventions: Procedure: VATS; Procedure: RATS

• Registration Number: NCT02804893
• Lead Sponsor: Istituto Clinico Humanitas

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-17
• Study Start: 2017-03-06
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-18
• Last Update Posted: 2018-12-20
• Primary Completion: 2022-03-06
• Study Completion: 2023-03-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VATS GROUP	VATS	VATS lobectomy or segmentectomy
RATS GROUP	RATS	Robotic lobectomy or segmentectomy

Primary Outcome Measures

Name	Time	Method
Postoperative complications: surgical complications, higher or equal grade II assessed by Clavien-Dindo scale, within 90 days	within 90 days
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

Secondary Outcome Measures

Name	Time	Method
Duration of analgesic use after discharge and time to return to normal daily activity	within 90 days
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
Proportion of patients who undergo complete resection during the procedure	date of Surgery
Postoperative hospital stay	2 weeks
Number of resected lymph nodes and upstaging	date of Surgery
Postoperative pain: daily evaluation with visual numeric scale before and after surgery until discharge	2 weeks, 6 months and 12 months
Duration of surgery	date of Surgery
Quality of life by EORTC QOL-C30	2 weeks, 6 months and 12 months
Postoperative respiratory function: FEV 1, PEF and CV	6 month postoperatively

Trial Locations

Locations (1)

Thoracic surgery Division, Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milan, Italy