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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02719717
Recruitment Status : Completed
First Posted : March 25, 2016
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Tracking Information
First Submitted Date  ICMJE January 28, 2016
First Posted Date  ICMJE March 25, 2016
Last Update Posted Date January 27, 2020
Study Start Date  ICMJE June 2016
Actual Primary Completion Date November 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2016)
  • Number of intra-operative transfusions [ Time Frame: Immediate, intra-operative ]
  • Number of post-operative transfusions [ Time Frame: After the surgery up to 30 days ]
  • Number of conversion to open surgery [ Time Frame: Immediate, intra-operative ]
  • Number of intra-operative mortality [ Time Frame: Immediate, intra-operative ]
  • Length of stay (days) [ Time Frame: After the surgery up to 30 days ]
  • Chest tube drainage per 24-hour period (mL) [ Time Frame: From the time of surgery to chest tube removal ]
  • Number of operative take-back for bleeding, source of bleeding [ Time Frame: During the hospitalisation (up to 30 days) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 24, 2016)
Number of morbidity and mortality [ Time Frame: From time of discharge to follow up 30 days ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Ultrasonic Energy for Pulmonary Artery Branch Sealing During VATS Lobectomy
Official Title  ICMJE Prospective, Multi-Center, International Phase 2 Trial of the Use of Ultrasonic Energy for Pulmonary Artery Branch Sealing During VATS Lobectomy
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE Device: Harmonic Ace+7
Pulmonary artery sealing with Harmonic Ace+7 in VATS lobectomy
Study Arms  ICMJE Experimental: Harmonic Ace+7
Pulmonary artery sealing with Harmonic Ace+7 in VATS lobectomy
Intervention: Device: Harmonic Ace+7
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2016)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 9, 2018
Actual Primary Completion Date November 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02719717
Other Study ID Numbers  ICMJE CE 15.302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Centre hospitalier de l'Université de Montréal (CHUM)
Study Sponsor  ICMJE Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators  ICMJE Johnson & Johnson
Investigators  ICMJE
Principal Investigator: Moishe Liberman, MD, PhD Centre hospitalier de l'Université de Montréal (CHUM)
PRS Account Centre hospitalier de l'Université de Montréal (CHUM)
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP