Powered Echelon Device in VATS Surgery

Completed

Brief Summary: 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
VATS for suspected or confirmed NSCLC	Endocutter	Single arm study

Primary Outcome Measures

Name	Time	Method
Occurrence of Prolonged Air Leaks	Post-operative period through hospital discharge and follow-up at Day 30	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).
Occurrence of Postoperative Air Leaks	Post-operative period through hospital discharge and follow-up at Day 30	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).

Secondary Outcome Measures

Name	Time	Method
Operative Time	Day of surgery	Defined as the duration in hours from the first skin incision to the closure of the last incision
Occurrence of Intra-operative Leak Test	During surgery	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.
Time to Chest Tube Removal	Post-operative period through hospital discharge and follow-up at Day 30	Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.
Length of Stay (LOS)	Post-operative period through hospital discharge and follow-up at Day 30	Determined as the length of time in days from hospital admission to initial hospital discharge
Volume of Estimated Intra-operative Blood Loss	Blood loss intra-op and up to 5 days post-op
Number of Subjects With 1 Chest Tube Placed	During surgery	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.

Locations (4): Dignity Health, St. Joseph's Hospital & Medical Center
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Phoenix, Arizona, United States
Washington University School of Medicine
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St. Louis, Missouri, United States
Vanderbilt University
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Nashville, Tennessee, United States
Massachusetts General Hospital
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Boston, Massachusetts, United States