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

January 22, 2020 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Monteal, Quebec, Canada, H2L 4M1
        • Centre Hospitalier de l'Universite de Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediate, intra-operative evaluation

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of intra-operative transfusions
Time Frame: Immediate, intra-operative
Immediate, intra-operative
Number of post-operative transfusions
Time Frame: After the surgery up to 30 days
After the surgery up to 30 days
Number of conversion to open surgery
Time Frame: Immediate, intra-operative
Immediate, intra-operative
Number of intra-operative mortality
Time Frame: Immediate, intra-operative
Immediate, intra-operative
Length of stay (days)
Time Frame: After the surgery up to 30 days
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
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)
During the hospitalisation (up to 30 days)

Other Outcome Measures

Outcome Measure
Time Frame
Number of morbidity and mortality
Time Frame: From time of discharge to follow up 30 days
From time of discharge to follow up 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Johnson & Johnson

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

November 9, 2018

Study Completion (Actual)

November 9, 2018

Study Registration Dates

First Submitted

January 28, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (Estimate)

March 25, 2016

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CE 15.302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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