Lung Cancer Clinical Trial
Official title:
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.
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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