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Lung CancerVATS PA-ACENCT02719717

Ultrasonic Energy for Pulmonary Artery Branch Sealing During VATS Lobectomy

A study testing Harmonic Ace+7 in people with Lung Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

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

This research program consists of a prospective, multi-institutional Phase 2 trial and an economic cost-effectiveness analysis for the use of ACE+7 in VATS lobectomy/segmentectomy compared to traditional techniques. 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?
Harmonic Ace+7
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteCanada
Study dates
Jun 2016to 9 Nov 2018
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

  • ability to consent
  • > 18 years old
  • non-hilar tumors
  • pre-operative imaging (chest CT and PET-CT
  • invasive mediastinal staging requirement will be based on current American College of Chest Physicians (ACCP) lung cancer staging criteria and will be performed by any of the following tests, in appropriate patients, alone or in combination based on study site preference in accordance with ACCP guidelines - mediastinoscopy, mediastinotomy, VATS, endobronchial ultrasound, endoscopic ultrasound.

Who cannot join

  • previous unilateral thoracic surgical procedure or trauma
  • history of mediastinal or pulmonary irradiation
  • anticoagulation with inability to stop anticoagulants prior to surgery
  • systemic vascular disease or vasculitis
  • uncorrectable coagulopathy
  • use of systemic steroids or immunosuppressive medication Pulmonary hypertension will not be an exclusion criterion as patients with pulmonary hypertension were shown to have higher bursting pressures following PA sealing in previous studies.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre Hospitalier de l'Université de Montréal

    Monteal, Quebec, H2L 4M1

Other trials in Canada

About this study

Official title: Prospective, Multi-Center, International Phase 2 Trial of the Use of Ultrasonic Energy for Pulmonary Artery Branch Sealing During VATS Lobectomy

This research program consists of a prospective, multi-institutional Phase 2 trial and an economic cost-effectiveness analysis for the use of ACE+7 in VATS lobectomy/segmentectomy compared to traditional techniques.

It will be left up to the study credentialed surgeon investigator to decide the suitability of PA branches for sealing. This will be decided intra-operatively based on anatomy, vascular dissection and length as well as patient specific factors.

Read the detailed description

Currently, a minority of anatomic pulmonary resections are being performed by VATS (15%). The technical difficulty and increased actual and perceived danger of VATS lobectomy is related to PA branch manipulation, stapling and division. This is the main limitation for many thoracic surgeons regarding the adoption of VATS lobectomy into their practice. Furthermore, the majority of VATS lobectomies are being performed in high volume, academic medical centers with a resultant disparity in socioeconomic status between those that undergo VATS versus open lobectomy. If we can find a way to decrease the manipulation required by the surgeon on the PA branches, these procedures will be safer, less stressful for the surgeon and therefore more prevalent for anatomical pulmonary resections.

Energy utilization in VATS lobectomy may also be more cost effective than endostaplers. The use of a single device for lymph node dissection, hilar dissection, and PA branch sealing may allow for overall procedural cost savings. There may also be a potential benefit in decreasing overall length of hospital stay due to decrease in chest tube duration secondary to decreased post-operative pleural fluid output following VATS lobectomy when using energy as opposed to cautery for mediastinal lymph node dissection.

Objectives:

  • Systematically evaluate the immediate, short- and medium-term efficacy and safety of PA sealing utilising ACE+7 in a human VATS Lobectomy/Segmentectomy.
  • Understand cost issues related to use of ACE+7 in human VATS Lobectomy/Segmentectomy.

General satisfaction of the surgeon utilizing energy sealing devices compared to standard endostaplers will be assessed using a post-procedural online survey administered by the research team immediately following each procedure.

This multi-institutional, international trial will be important to decrease the bias associated with single center studies and bolster the confidence level of thoracic surgeons in the results of the trial. Study sites have been specifically chosen in the USA, Canada and Europe in order to increase the worldwide generalizability of results.

Conditions
Lung Cancer
Being tested
Harmonic Ace+7
Keywords
VATS lobectomy, vascular sealing, energy, pulmonary artery
Medical subject headings
Lung Neoplasms

What participants receive

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

  • Harmonic Ace+7Device

    Pulmonary artery sealing with Harmonic Ace+7 in VATS lobectomy

Study groups in NCT02719717
Study groupRoleWhat they receive
Harmonic Ace+7ExperimentalPulmonary artery sealing with Harmonic Ace+7 in VATS lobectomy
Receives: Device: Harmonic Ace+7

What is being measured

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

  1. For technical success absence of intra-operative bleeding directly related to PA branch ACE+7 sealing on vessels ≤7mm.

    All procedures will be video-recorded for intra-operative assessment of vascular manipulation, vessel sealing and bleeding episodes using high definition thoracoscope video recorder.

    Measured: Immediate, intra-operative evaluation

Secondary outcomes (7)

  1. Number of intra-operative transfusions

    Measured: Immediate, intra-operative

  2. Number of post-operative transfusions

    Measured: After the surgery up to 30 days

  3. Number of conversion to open surgery

    Measured: Immediate, intra-operative

  4. Number of intra-operative mortality

    Measured: Immediate, intra-operative

  5. Length of stay (days)

    Measured: After the surgery up to 30 days

  6. Chest tube drainage per 24-hour period (mL)

    Measured: From the time of surgery to chest tube removal

  7. Number of operative take-back for bleeding, source of bleeding

    Measured: During the hospitalisation (up to 30 days)

Timeline

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

  1. First posted25 Mar 2016 (estimated)
  2. Study startJun 2016
  3. Primary completion9 Nov 2018
  4. Study completion9 Nov 2018

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02719717
Sponsor's protocol ID
CE 15.302
Acronym
VATS PA-ACE
Status last verified
Mar 2018
First submitted
28 Jan 2016
Last updated
27 Jan 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • Liberman M, Khereba M, Goudie E, Kazakov J, Thiffault V, Lafontaine E, Ferraro P. Pilot study of pulmonary arterial branch sealing using energy devices in an ex vivo model. J Thorac Cardiovasc Surg. 2014 Dec;148(6):3219-23. doi: 10.1016/j.jtcvs.2014.05.089. Epub 2014 Jul 19.

    PubMed 25125207

  • Goudie E, Khereba M, Tahiri M, Hegde P, Thiffault V, Hadjeres R, Berdugo J, Ferraro P, Liberman M. Pulmonary Artery Sealing With an Ultrasonic Energy Device in Video-Assisted Thoracoscopic Surgery Lobectomy: An Animal Survival Study. Ann Thorac Surg. 2016 Oct;102(4):1088-94. doi: 10.1016/j.athoracsur.2016.04.050. Epub 2016 Jun 24.

    PubMed 27345091

  • Liberman M, Khereba M, Nasir B, Goudie E, Danino A, Giot JP, Nizard N, Hadjeres R, Thiffault V, Farrenq N, Ferraro P. Pulmonary Artery Sealing Using the HARMONIC ACE+ Shears for Video-Assisted Thoracoscopic Surgery Lobectomy. Ann Thorac Surg. 2015 Sep;100(3):898-903; discussion 903-4. doi: 10.1016/j.athoracsur.2015.04.063. Epub 2015 Jul 21.

    PubMed 26209484

  • Liberman M, Goudie E, Morse C, Hanna W, Evans N, Yasufuku K, Sampalis J; VATS PA Study Working Group. Prospective, multicenter, international phase 2 trial evaluating ultrasonic energy for pulmonary artery branch sealing in video-assisted thoracoscopic surgery lobectomy. J Thorac Cardiovasc Surg. 2020 Jan;159(1):301-311. doi: 10.1016/j.jtcvs.2019.09.061. Epub 2019 Sep 30.

    PubMed 31679701

Questions about this trial

What is this clinical trial studying?

A study testing Harmonic Ace+7 in people with Lung Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

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 6 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 27 Jan 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 Canada. 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?

For technical success absence of intra-operative bleeding directly related to PA branch ACE+7 sealing on vessels ≤7mm. (time frame: Immediate, intra-operative evaluation). 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 NCT02719717, which also lists 4 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 27 Jan 2020.

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