Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in Korea

Study Overview
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Brief Summary
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Collection of 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) in a Korean population.

Detailed Description
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This clinical trial assessed the use of a powered stapler for transection in VATS lung resection, where there is currently limited published clinical data. The primary study endpoint was occurrence and duration of air leak / prolonged air leak (PAL). Procedure details and perioperative outcomes associated with VATS lung resections were also evaluated.

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

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 of NSCLC (up to and including Stage II), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC); 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; and At least 19 years of age. Exclusion Criteria: Active (subject currently receiving systemic treatment) bacterial infection or fungal infection; Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain 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: 19 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 wedge resection or lobectomy<br>Single arm study Intervention: Device: Endocutter | Device: Endocutter<br>* The study utilized Echelon FlexTM Powered ENDOPATH® Stapler (Ethicon, Cincinnati, USA) along with compatible cartridges: Gray (closed staple height, 0.75mm), White (1.0mm), Blue (1.5mm), Gold (1.8mm), Green (2.0mm), and Black (2.3mm).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). | Post-operative period through hospital discharge and follow-up at Day 30 | 

Secondary 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). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). | Post-operative period through hospital discharge and follow-up at Day 30 | 
| 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 |