Prospective, Multi-Center, International Phase 2 Trial of the Use of Ultrasonic Energy for Pulmonary Artery Branch Sealing During VATS Lobectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- For technical success absence of intra-operative bleeding directly related to PA branch ACE+7 sealing on vessels ≤7mm.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Harmonic Ace+7
Pulmonary artery sealing with Harmonic Ace+7 in VATS lobectomy
Intervention: Harmonic Ace+7 (Device)
Outcomes
Primary Outcomes
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 Outcomes
- Number of post-operative transfusions(After the surgery up to 30 days)
- Number of intra-operative mortality(Immediate, intra-operative)
- Chest tube drainage per 24-hour period (mL)(From the time of surgery to chest tube removal)
- Number of intra-operative transfusions(Immediate, intra-operative)
- Length of stay (days)(After the surgery up to 30 days)
- Number of conversion to open surgery(Immediate, intra-operative)
- Number of operative take-back for bleeding, source of bleeding(During the hospitalisation (up to 30 days))