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Lung CancerROMANNCT02804893

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

A study testing VATS and RATS in people with Lung Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
VATS and RATS
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteItaly
Study dates
6 Mar 2017to 6 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site, 1 recruiting

  • Thoracic surgery Division, Istituto Clinico Humanitas

    Rozzano, Milan, 20089

    Giulia Veronesi, MD, +39 (0)2 82247396, giulia.veronesi@cancercenter.humanitas.it

    Elisa Dieci, PhD, +39(0)282244594, elisa.dieci@cancercenter.humanitas.it

    Recruiting

Other trials in Italy

About this study

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)

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.

Conditions
Lung Cancer
Being tested
VATS, RATS
Keywords
Lung cancer, video-assisted thoracoscopic surgery, robotic-assisted thoracoscopic surgery
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VATSProcedure or surgery

    Also called Minimally invasive video-assisted surgery

    Thorax thoracoscopic surgery (lobectomy)

  • RATSProcedure or surgery

    Also called Minimally invasive robot-assisted surgery

    Thorax robotic surgery (lobectomy)

Study groups in NCT02804893
Study groupRoleWhat they receive
VATS GROUPActive comparatorVATS lobectomy or segmentectomy
Receives: Procedure: VATS
RATS GROUPActive comparatorRobotic lobectomy or segmentectomy
Receives: Procedure: RATS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: date of Surgery

  2. Postoperative complications: surgical complications, higher or equal grade II assessed by Clavien-Dindo scale, within 90 days

    Measured: within 90 days

Secondary outcomes (10)

  1. Duration of surgery

    Measured: date of Surgery

  2. Number of resected lymph nodes and upstaging

    Measured: date of Surgery

  3. Proportion of patients who undergo complete resection during the procedure

    Measured: date of Surgery

  4. Postoperative hospital stay

    Measured: 2 weeks

  5. Postoperative pain: daily evaluation with visual numeric scale before and after surgery until discharge

    Measured: 2 weeks, 6 months and 12 months

  6. Quality of life by EORTC QOL-C30

    Measured: 2 weeks, 6 months and 12 months

  7. Duration of analgesic use after discharge and time to return to normal daily activity

    Measured: within 90 days

  8. Postoperative respiratory function: FEV 1, PEF and CV

    Measured: 6 month postoperatively

  9. Rate of local and distant recurrence and disease free survival

    Measured: 24 months

  10. Patient's immune response: analysis of PCR, serum interleukins, lymphocytes subpopulations

    Measured: before surgery, 2 hours after surgery and at 3rd and 14th postoperative day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2016 (estimated)
  2. Study start6 Mar 2017
  3. Primary completion6 Mar 2022 (estimated)
  4. Study completion6 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02804893
Sponsor's protocol ID
1566
Acronym
ROMAN
Status last verified
Dec 2018
First submitted
15 Jun 2016
Last updated
20 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 10421140

  • 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.

    PubMed 12632277

  • 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.

    PubMed 11016337

  • 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.

    PubMed 12560900

  • 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.

    PubMed 10921716

  • 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.

    PubMed 12614812

  • 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.

    PubMed 9930466

  • 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.

    PubMed 12895606

  • 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.

    PubMed 9800798

  • 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.

    PubMed 24504007

  • 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.

    PubMed 12238851

  • 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.

    PubMed 12062276

  • 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.

    PubMed 16399294

  • 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.

    PubMed 19632377

  • 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.

    PubMed 20038475

Questions about this trial

What is this clinical trial studying?

A study testing VATS and RATS in people with Lung Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: date of Surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02804893, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.

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