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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Harmonic Ace+7 | Experimental | Pulmonary artery sealing with Harmonic Ace+7 in VATS lobectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harmonic Ace+7 | Device | Pulmonary artery sealing with Harmonic Ace+7 in VATS lobectomy |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of morbidity and mortality | From time of discharge to follow up 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moishe Liberman, MD, PhD | Centre hospitalier de l'Université de Montréal (CHUM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de l'Université de Montréal | Monteal | Quebec | H2L 4M1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25125207 | Background | Liberman M, Khereba M, Goudie E, Kazakov J, Thiffault V, Lafontaine E, Ferraro P. Pilot study of pulmonary arterial branch sealing using energy devices in an ex vivo model. J Thorac Cardiovasc Surg. 2014 Dec;148(6):3219-23. doi: 10.1016/j.jtcvs.2014.05.089. Epub 2014 Jul 19. | |
| 27345091 | Background | Goudie E, Khereba M, Tahiri M, Hegde P, Thiffault V, Hadjeres R, Berdugo J, Ferraro P, Liberman M. Pulmonary Artery Sealing With an Ultrasonic Energy Device in Video-Assisted Thoracoscopic Surgery Lobectomy: An Animal Survival Study. Ann Thorac Surg. 2016 Oct;102(4):1088-94. doi: 10.1016/j.athoracsur.2016.04.050. Epub 2016 Jun 24. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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) |
| 26209484 | Result | Liberman M, Khereba M, Nasir B, Goudie E, Danino A, Giot JP, Nizard N, Hadjeres R, Thiffault V, Farrenq N, Ferraro P. Pulmonary Artery Sealing Using the HARMONIC ACE+ Shears for Video-Assisted Thoracoscopic Surgery Lobectomy. Ann Thorac Surg. 2015 Sep;100(3):898-903; discussion 903-4. doi: 10.1016/j.athoracsur.2015.04.063. Epub 2015 Jul 21. |
| 31679701 | Derived | Liberman M, Goudie E, Morse C, Hanna W, Evans N, Yasufuku K, Sampalis J; VATS PA Study Working Group. Prospective, multicenter, international phase 2 trial evaluating ultrasonic energy for pulmonary artery branch sealing in video-assisted thoracoscopic surgery lobectomy. J Thorac Cardiovasc Surg. 2020 Jan;159(1):301-311. doi: 10.1016/j.jtcvs.2019.09.061. Epub 2019 Sep 30. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |