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Early Stage Non-small-cell Lung Cancer (Stage 1-2)NCT03925103

Assessment of Ergonomics in 3D vs 2D Thoracoscopic Lobectomy

A study testing 3D VATS lobectomy and 2D VATS lobectomy in people with Early Stage Non-small-cell Lung Cancer (Stage 1-2), run by University of Rome Tor Vergata at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Video-assisted thoracic surgery (VATS) pulmonary lobectomy is currently widely employed as the first treatment option for surgical management of early stage (stage I-II) non-small-cell-lung-cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
3D VATS lobectomy and 2D VATS lobectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteItaly
Study dates
1 Oct 2018to 31 Dec 2019
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical NSCLC early stage (stage I-II).
  • Both forced expiratory volume in one second (FEV1) and diffusion capacity of carbon monoxide (DLCO)>60%
  • Both predicted postoperative (PPO) FEV1 and PPO DLCO >35%
  • American Society of Anesthesia (ASA) score<=2
  • Body mass index (BMI) >18 <28

Who cannot join

  • Clinical NSCLC stage> II
  • History of Neoadjuvant chemotherapy or radiotherapy
  • Radiologic evidence of extensive pleural adhesions.
  • Age <18 or >80 years.
  • Patients with previous pleurodesis or thoracotomy in the affected hemithorax.
  • Patients who will undergo surgical lung resection other than lobectomy.
  • Patients with severe comorbidity contraindicating lobectomy.
  • Patients refusal or noncompliance to general surgery and one-lung ventilation.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Policlinico Tor Vergata University

    Roma, 00133

Other trials in Italy

About this study

Official title: Ergonomical Assessment of Three-Dimensional Versus Two-Dimensional Thoracoscopic Lobectomy for Lung Cancer

Video-assisted thoracic surgery (VATS) pulmonary lobectomy is currently widely employed as the first treatment option for surgical management of early stage (stage I-II) non-small-cell-lung-cancer (NSCLC).

Thanks to recent technological advances in high definition display systems, three dimensional VATS (3D) has been developed in an attempt of overcoming some optical limits of two dimensional (2D) VATS.

In this single center randomized trial our aim is to comparatively assess ergonomics of 3D versus 2D VATS lobectomy for early stage NSCLC.

Read the detailed description

Video-assisted thoracic surgery (VATS) is widely employed for pulmonary lobectomy in early stage non-small-cell-lung-cancer (NSCLC). Indeed, VATS is thought to represent an optimal minimally invasive surgical option which is deemed superior to conventional thoracotomy since it enables smaller incisions with no rib spreading thus minimizing both postoperative pain and hospital stay.

For over than three decades, several thoracic surgeons adopted VATS for anatomical lung resection using two-dimensional (2D) display systems. However, a 2D image lacks depth of perception which may negatively affect surgical manoeuvring.

Three dimensional (3D) display systems for VATS can offer superior magnified vision of the surgical field and better perception of depth during surgical manoeuvring potentially shortening learning curve, which may thus overcome some optical limitations of 2D systems.

In this single center randomized trial our aim is to comparatively assess ergonomics of 3D versus 2D VATS lobectomy for early stage (stage I-II) NSCLC. For this purpose we compared three ergonomical domains: exposure, instrumentation and maneuvering with the aid of a scoring scale entailing analysis of 5 main technical steps: vein, artery bronchus, lymph node and fissure score.

The evaluation process of the five surgical steps was carried out by 4 thoracic surgeons who individually scored all recorded operations.

Being tested
3D VATS lobectomy, 2D VATS lobectomy
Keywords
VATS, Lobectomy, 3D VATS, VATS Ergonomics, Non small cell lung cancer, Three-dimensional thoracoscopy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • 3D VATS lobectomyProcedure or surgery

    pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 3 dimensional display system

  • 2D VATS lobectomyProcedure or surgery

    pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 2 dimensional display system

Study groups in NCT03925103
Study groupRoleWhat they receive
3D VATS lobectomyExperimentalPatients undergo thoracoscopic lobectomy by a three-dimensional display system
Receives: Procedure: 3D VATS lobectomy
2D VATS lobectomyActive comparatorPatients undergo thoracoscopic lobectomy by a two-dimensional display system
Receives: Procedure: 2D VATS lobectomy

What is being measured

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

  1. a difference ≥10% in the score calculated for the maneuvring ergonomical domain.

    3 ergonomical domains: exposure, instrumentation and maneuvering are assessed by 4 thoracic surgeons using a new scoring scale (score range 1, unsatisfactory to 3 excellent). Primary outcome is a difference ≥10% (sd=0.3) in at least one of the evaluated domains.

    Measured: one week after surgery

Secondary outcomes (8)

  1. Operative time

    Total duration (min) of the surgical procedure from first incision opening to last incision closure

    Measured: during surgery

  2. intraoperative bleeding

    Total amount of blood (mL) lost during the surgical procedure

    Measured: intraoperative

  3. postoperative drainage volume

    Total amount of fluid (mL) collected through the chest drain during in-hospital stay

    Measured: two weeks after surgery

  4. surgical mortality

    Fatal complications occurryng within 90 days after surgery

    Measured: 90 days after surgery

  5. complications

    Any adverse event recorded perioperatively or after the surgical procedure during in-hospital stay

    Measured: 30 days after surgery

  6. hospital stay

    Overall duration (days) of in-hospital stay after the surgical procedure

    Measured: 30 days after surgery

  7. a difference ≥10% in the score calculated for the exposure ergonomical domain.

    3 ergonomical domains: exposure, instrumentation and maneuvering are assessed by 4 thoracic surgeons using a new scoring scale (score range 1, unsatisfactory to 3 excellent). Primary outcome is a difference ≥10% (sd=0.3) in at least one of the evaluated domains.

    Measured: one week after surgery

  8. a difference ≥10% in the score calculated for the instrumentation ergonomical domain.

    3 ergonomical domains: exposure, instrumentation and maneuvering are assessed by 4 thoracic surgeons using a new scoring scale (score range 1, unsatisfactory to 3 excellent). Primary outcome is a difference ≥10% (sd=0.3) in at least one of the evaluated domains.

    Measured: one week after surgery

Timeline

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

  1. First posted23 Apr 2019
  2. Study start1 Oct 2018
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2019

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
Model description
One to one parallel assignment to each treatment
Masking
Single blind
Who is masked
Participant
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03925103
Sponsor's protocol ID
2019-1RT
Status last verified
Apr 2020
First submitted
27 Feb 2019
Last updated
8 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Scott WJ, Allen MS, Darling G, Meyers B, Decker PA, Putnam JB, McKenna RW, Landrenau RJ, Jones DR, Inculet RI, Malthaner RA. Video-assisted thoracic surgery versus open lobectomy for lung cancer: a secondary analysis of data from the American College of Surgeons Oncology Group Z0030 randomized clinical trial. J Thorac Cardiovasc Surg. 2010 Apr;139(4):976-81; discussion 981-3. doi: 10.1016/j.jtcvs.2009.11.059. Epub 2010 Feb 20.

    PubMed 20172539

  • Villamizar NR, Darrabie MD, Burfeind WR, Petersen RP, Onaitis MW, Toloza E, Harpole DH, D'Amico TA. Thoracoscopic lobectomy is associated with lower morbidity compared with thoracotomy. J Thorac Cardiovasc Surg. 2009 Aug;138(2):419-25. doi: 10.1016/j.jtcvs.2009.04.026.

    PubMed 19619789

  • Xu Y, Chen N, Ma A, Wang Z, Zhang Y, Liu C, Liu L. Three-dimensional versus two-dimensional video-assisted thoracic surgery for thoracic disease: a meta-analysis. Interact Cardiovasc Thorac Surg. 2017 Dec 1;25(6):862-871. doi: 10.1093/icvts/ivx219.

    PubMed 29049786

  • Bagan P, De Dominicis F, Hernigou J, Dakhil B, Zaimi R, Pricopi C, Le Pimpec Barthes F, Berna P. Complete thoracoscopic lobectomy for cancer: comparative study of three-dimensional high-definition with two-dimensional high-definition video systems dagger. Interact Cardiovasc Thorac Surg. 2015 Jun;20(6):820-3. doi: 10.1093/icvts/ivv031. Epub 2015 Mar 3.

    PubMed 25736286

  • Jiao P, Wu QJ, Sun YG, Ma C, Tian WX, Yu HB, Tong HF. Comparative study of three-dimensional versus two-dimensional video-assisted thoracoscopic two-port lobectomy. Thorac Cancer. 2017 Jan;8(1):3-7. doi: 10.1111/1759-7714.12387. Epub 2016 Oct 4.

    PubMed 27755803

  • Dong S, Yang XN, Zhong WZ, Nie Q, Liao RQ, Lin JT, Wu YL. Comparison of three-dimensional and two-dimensional visualization in video-assisted thoracoscopic lobectomy. Thorac Cancer. 2016 Sep;7(5):530-534. doi: 10.1111/1759-7714.12361. Epub 2016 May 23.

    PubMed 27766782

  • Yan TD, Black D, Bannon PG, McCaughan BC. Systematic review and meta-analysis of randomized and nonrandomized trials on safety and efficacy of video-assisted thoracic surgery lobectomy for early-stage non-small-cell lung cancer. J Clin Oncol. 2009 May 20;27(15):2553-62. doi: 10.1200/JCO.2008.18.2733. Epub 2009 Mar 16.

    PubMed 19289625

Questions about this trial

What is this clinical trial studying?

A study testing 3D VATS lobectomy and 2D VATS lobectomy in people with Early Stage Non-small-cell Lung Cancer (Stage 1-2), run by University of Rome Tor Vergata 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 8 Apr 2020. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

a difference ≥10% in the score calculated for the maneuvring ergonomical domain. (time frame: one week after surgery). 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 NCT03925103, which also lists 7 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 8 Apr 2020.

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