NCT02804893

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

March 6, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2023

Completed
Last Updated

December 20, 2018

Status Verified

December 1, 2018

Enrollment Period

5 years

First QC Date

June 15, 2016

Last Update Submit

December 18, 2018

Conditions

Lung Cancer

Keywords

Lung cancer, video-assisted thoracoscopic surgery, robotic-assisted thoracoscopic surgery

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • Duration of surgery

    date of Surgery

  • Number of resected lymph nodes and upstaging

    date of Surgery

  • 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

  • +5 more secondary outcomes

Study Arms (2)

VATS GROUP

ACTIVE COMPARATOR

VATS lobectomy or segmentectomy

Procedure: VATS

RATS GROUP

ACTIVE COMPARATOR

Robotic lobectomy or segmentectomy

Procedure: RATS

Interventions

VATSPROCEDURE

Thorax thoracoscopic surgery (lobectomy)

Also known as: Minimally invasive video-assisted surgery
VATS GROUP
RATSPROCEDURE

Thorax robotic surgery (lobectomy)

Also known as: Minimally invasive robot-assisted surgery
RATS GROUP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Clinical stage \>II
  • Severe heart disease
  • Alcohol abuse
  • Renal impairment (creatinine \>2.5)
  • Presence of serious comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thoracic surgery Division, Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

RECRUITING

Related Publications (18)

  • Demmy TL, Curtis JJ. Minimally invasive lobectomy directed toward frail and high-risk patients: a case-control study. Ann Thorac Surg. 1999 Jul;68(1):194-200. doi: 10.1016/s0003-4975(99)00467-1.

    PMID: 10421140RESULT

  • Hoksch B, Ablassmaier B, Walter M, Muller JM. [Complication rate after thoracoscopic and conventional lobectomy]. Zentralbl Chir. 2003 Feb;128(2):106-10. doi: 10.1055/s-2003-37763. German.

    PMID: 12632277RESULT

  • Nakata M, Saeki H, Yokoyama N, Kurita A, Takiyama W, Takashima S. Pulmonary function after lobectomy: video-assisted thoracic surgery versus thoracotomy. Ann Thorac Surg. 2000 Sep;70(3):938-41. doi: 10.1016/s0003-4975(00)01513-7.

    PMID: 11016337RESULT

  • Nomori H, Ohtsuka T, Horio H, Naruke T, Suemasu K. Difference in the impairment of vital capacity and 6-minute walking after a lobectomy performed by thoracoscopic surgery, an anterior limited thoracotomy, an anteroaxillary thoracotomy, and a posterolateral thoracotomy. Surg Today. 2003;33(1):7-12. doi: 10.1007/s005950300001.

    PMID: 12560900RESULT

  • Yim AP, Wan S, Lee TW, Arifi AA. VATS lobectomy reduces cytokine responses compared with conventional surgery. Ann Thorac Surg. 2000 Jul;70(1):243-7. doi: 10.1016/s0003-4975(00)01258-3.

    PMID: 10921716RESULT

  • Li WW, Lee RL, Lee TW, Ng CS, Sihoe AD, Wan IY, Arifi AA, Yim AP. The impact of thoracic surgical access on early shoulder function: video-assisted thoracic surgery versus posterolateral thoracotomy. Eur J Cardiothorac Surg. 2003 Mar;23(3):390-6. doi: 10.1016/s1010-7940(02)00795-9.

    PMID: 12614812RESULT

  • McKenna RJ Jr, Wolf RK, Brenner M, Fischel RJ, Wurnig P. Is lobectomy by video-assisted thoracic surgery an adequate cancer operation? Ann Thorac Surg. 1998 Dec;66(6):1903-8. doi: 10.1016/s0003-4975(98)01166-7.

    PMID: 9930466RESULT

  • Leschber G, Holinka G, Linder A. Video-assisted mediastinoscopic lymphadenectomy (VAMLA)--a method for systematic mediastinal lymphnode dissection. Eur J Cardiothorac Surg. 2003 Aug;24(2):192-5. doi: 10.1016/s1010-7940(03)00253-7.

    PMID: 12895606RESULT

  • Yim AP, Landreneau RJ, Izzat MB, Fung AL, Wan S. Is video-assisted thoracoscopic lobectomy a unified approach? Ann Thorac Surg. 1998 Oct;66(4):1155-8. doi: 10.1016/s0003-4975(98)00622-5.

    PMID: 9800798RESULT

  • Cao C, Tian DH, Wolak K, Oparka J, He J, Dunning J, Walker WS, Yan TD. Cross-sectional survey on lobectomy approach (X-SOLA). Chest. 2014 Aug;146(2):292-298. doi: 10.1378/chest.13-1075.

    PMID: 24504007RESULT

  • Daniels LJ, Balderson SS, Onaitis MW, D'Amico TA. Thoracoscopic lobectomy: a safe and effective strategy for patients with stage I lung cancer. Ann Thorac Surg. 2002 Sep;74(3):860-4. doi: 10.1016/s0003-4975(02)03764-5.

    PMID: 12238851RESULT

  • Melfi FM, Menconi GF, Mariani AM, Angeletti CA. Early experience with robotic technology for thoracoscopic surgery. Eur J Cardiothorac Surg. 2002 May;21(5):864-8. doi: 10.1016/s1010-7940(02)00102-1.

    PMID: 12062276RESULT

  • Park BJ, Flores RM, Rusch VW. Robotic assistance for video-assisted thoracic surgical lobectomy: technique and initial results. J Thorac Cardiovasc Surg. 2006 Jan;131(1):54-9. doi: 10.1016/j.jtcvs.2005.07.031.

    PMID: 16399294RESULT

  • Gharagozloo F, Margolis M, Tempesta B, Strother E, Najam F. Robot-assisted lobectomy for early-stage lung cancer: report of 100 consecutive cases. Ann Thorac Surg. 2009 Aug;88(2):380-4. doi: 10.1016/j.athoracsur.2009.04.039.

    PMID: 19632377RESULT

  • Veronesi G, Galetta D, Maisonneuve P, Melfi F, Schmid RA, Borri A, Vannucci F, Spaggiari L. Four-arm robotic lobectomy for the treatment of early-stage lung cancer. J Thorac Cardiovasc Surg. 2010 Jul;140(1):19-25. doi: 10.1016/j.jtcvs.2009.10.025. Epub 2009 Dec 28.

    PMID: 20038475RESULT

  • Louie BE, Farivar AS, Aye RW, Vallieres E. Early experience with robotic lung resection results in similar operative outcomes and morbidity when compared with matched video-assisted thoracoscopic surgery cases. Ann Thorac Surg. 2012 May;93(5):1598-604; discussion 1604-5. doi: 10.1016/j.athoracsur.2012.01.067. Epub 2012 Mar 20.

    PMID: 22440364RESULT

  • Nakamura H. Systematic review of published studies on safety and efficacy of thoracoscopic and robot-assisted lobectomy for lung cancer. Ann Thorac Cardiovasc Surg. 2014;20(2):93-8. doi: 10.5761/atcs.ra.13-00314. Epub 2014 Feb 28.

    PMID: 24583699RESULT

  • Veronesi G, Abbas AE, Muriana P, Lembo R, Bottoni E, Perroni G, Testori A, Dieci E, Bakhos CT, Car S, Luzzi L, Alloisio M, Novellis P. Perioperative Outcome of Robotic Approach Versus Manual Videothoracoscopic Major Resection in Patients Affected by Early Lung Cancer: Results of a Randomized Multicentric Study (ROMAN Study). Front Oncol. 2021 Sep 9;11:726408. doi: 10.3389/fonc.2021.726408. eCollection 2021.

    PMID: 34568057DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ThoracoscopyEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisVideo-Assisted SurgeryMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 17, 2016

Study Start

March 6, 2017

Primary Completion

March 6, 2022

Study Completion

March 6, 2023

Last Updated

December 20, 2018

Record last verified: 2018-12

Locations

IT(1)