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Ultrasonic Energy for Pulmonary Artery Branch Sealing During VATS Lobectomy (VATS PA-ACE)

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ClinicalTrials.gov Identifier: NCT02719717
Recruitment Status : Recruiting
First Posted : March 25, 2016
Last Update Posted : March 30, 2018
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Lung Cancer Device: Harmonic Ace+7 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Multi-Center, International Phase 2 Trial of the Use of Ultrasonic Energy for Pulmonary Artery Branch Sealing During VATS Lobectomy
Study Start Date : June 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Harmonic Ace+7
Pulmonary artery sealing with Harmonic Ace+7 in VATS lobectomy
Device: Harmonic Ace+7
Pulmonary artery sealing with Harmonic Ace+7 in VATS lobectomy




Primary Outcome Measures :
  1. 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 ]
    All procedures will be video-recorded for intra-operative assessment of vascular manipulation, vessel sealing and bleeding episodes using high definition thoracoscope video recorder.


Secondary Outcome Measures :
  1. Number of intra-operative transfusions [ Time Frame: Immediate, intra-operative ]
  2. Number of post-operative transfusions [ Time Frame: After the surgery up to 30 days ]
  3. Number of conversion to open surgery [ Time Frame: Immediate, intra-operative ]
  4. Number of intra-operative mortality [ Time Frame: Immediate, intra-operative ]
  5. Length of stay (days) [ Time Frame: After the surgery up to 30 days ]
  6. Chest tube drainage per 24-hour period (mL) [ Time Frame: From the time of surgery to chest tube removal ]
  7. Number of operative take-back for bleeding, source of bleeding [ Time Frame: During the hospitalisation (up to 30 days) ]

Other Outcome Measures:
  1. Number of morbidity and mortality [ Time Frame: From time of discharge to follow up 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ability to consent
  2. > 18 years old
  3. non-hilar tumors
  4. pre-operative imaging (chest CT and PET-CT
  5. 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.

Exclusion Criteria:

  1. previous unilateral thoracic surgical procedure or trauma
  2. history of mediastinal or pulmonary irradiation
  3. anticoagulation with inability to stop anticoagulants prior to surgery
  4. systemic vascular disease or vasculitis
  5. uncorrectable coagulopathy
  6. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02719717


Contacts
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Contact: Moishe Liberman, MD, PhD 514-890-8000 ext 26832 moishe.liberman@umontreal.ca
Contact: Vicky Thiffault, BScN, CCRP 514-890-8000 ext 23432 vicky.thiffault.chum@ssss.gouv.qc.ca

Locations
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Canada, Quebec
Centre Hospitalier de l'Université de Montréal Recruiting
Monteal, Quebec, Canada, H2L 4M1
Contact: Vicky Thiffault, BScN, CCRP    514-890-8000 ext 23432    vicky.thiffault.chum@ssss.gouv.qc.ca   
Contact: Moishe Liberman, MD, PhD    514-890-8000 ext 26832      
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Johnson & Johnson
Investigators
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Principal Investigator: Moishe Liberman, MD, PhD Centre hospitalier de l'Université de Montréal (CHUM)

Publications of Results:
Other Publications:
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02719717     History of Changes
Other Study ID Numbers: CE 15.302
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
VATS lobectomy
vascular sealing
energy
pulmonary artery