Ultrasonic Energy for Pulmonary Artery Branch Sealing During VATS Lobectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: Harmonic Ace+7


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Harmonic Ace+7<br>Pulmonary artery sealing with Harmonic Ace+7 in VATS lobectomy | Device: Harmonic Ace+7<br>* Pulmonary artery sealing with Harmonic Ace+7 in VATS lobectomy<br>|

What is the study measuring?
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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. | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Number of intra-operative transfusions |  | Immediate, intra-operative | 
| Number of post-operative transfusions |  | After the surgery up to 30 days | 
| Number of conversion to open surgery |  | Immediate, intra-operative | 
| Number of intra-operative mortality |  | Immediate, intra-operative | 
| Length of stay (days) |  | After the surgery up to 30 days | 
| Chest tube drainage per 24-hour period (mL) |  | From the time of surgery to chest tube removal | 
| Number of operative take-back for bleeding, source of bleeding |  | During the hospitalisation (up to 30 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VATS lobectomy, vascular sealing, energy, pulmonary artery