Powered Echelon Device in VATS Surgery

Study Overview
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Brief Summary
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This study aims to collect real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm and/or 60 mm (study devices).

Official Title
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A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures

Conditions
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Non-small Cell Lung Cancer (NSCLC)

Intervention / Treatment
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* Device: Endocutter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suspected or confirmed NSCLC (up to and including Stage II) Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung Performance status 0-1 (Eastern Cooperative Oncology Group classification) ASA score < 3 No prior history of VATS or open lung surgery Willing to give consent and comply with study-related evaluation and treatment schedule Exclusion Criteria: Active bacterial infection or fungal infection; Systemic administration (intravenous or oral) of steroids (within 30 days prior to study procedure) Chemotherapy or radiation therapy for lung cancer may not be performed for 30 days prior to the procedure Scheduled concurrent surgical procedure other than wedge resection or lobectomy (central venous access - e.g. port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed) Pregnancy Physical or psychological condition which would impair study participation; The patient is judged unsuitable for study participation by the Investigator for any other reason; or Unable or unwilling to attend follow-up visits and examinations

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VATS for suspected or confirmed NSCLC<br>Single arm study | Device: Endocutter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Postoperative Air Leaks | Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers). | Post-operative period through hospital discharge and follow-up at Day 30 | 
| Occurrence of Prolonged Air Leaks | Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers). | Post-operative period through hospital discharge and follow-up at Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay (LOS) | Determined as the length of time in days from hospital admission to initial hospital discharge | Post-operative period through hospital discharge and follow-up at Day 30 | 
| Volume of Estimated Intra-operative Blood Loss |  | Blood loss intra-op and up to 5 days post-op | 
| Time to Chest Tube Removal | Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure. | Post-operative period through hospital discharge and follow-up at Day 30 | 
| Operative Time | Defined as the duration in hours from the first skin incision to the closure of the last incision | Day of surgery | 
| Occurrence of Intra-operative Leak Test | This outcome was scored as Yes or No based on whether a leak was detected during an intra-operative leak test when it was performed. Not all subjects had an intra-operative leak test performed, as it was not standard of care at all participating institutions, and so results are only presented for those subjects in whom an intra-operative test was performed. | During surgery | 
| Number of Subjects With 1 Chest Tube Placed | All subjects had either 1 or 2 chest tubes placed during surgery. Results presented are for the percentage of subjects with 1 chest tube placed. | During surgery |