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).

Detailed Description
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The European prospective observational multi-center cohort study aims to collect real-world outcomes of consecutive patients scheduled for VATS lobectomy for histologically confirmed Non-Small Cell Lung Cancer (NSCLC) or scheduled for VATS wedge resection for undiagnosed pulmonary nodule or metastasis from colorectal cancer (CRC) in accordance with their institution's Standard-of-care (SOC).

Official Title
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Real World Outcomes of Video-Assisted Thoracoscopic Surgery for Lung Cancer Using ECHELON FLEX™ Powered ENDOPATH® Stapler: a Prospective European Multicenter Study

Conditions
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Non-small Cell Lung Cancer (NSCLC)

Intervention / Treatment
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* Procedure: VATS for confirmed non-small cell lung cancer (NSCLC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed NSCLC (up to and including Stage II) for patients undergoing VATS lobectomy. For patients undergoing wedge resection for undiagnosed pulmonary nodule or metastasis from CRC, a malignant diagnosis may be confirmed post-operatively. Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung Willing to give consent and comply with evaluation and treatment schedule At least 18 years of age 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); Prior history of VATS or open lung surgery

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 NSCLC patients<br>VATS for confirmed non-small cell lung cancer (NSCLC) | Procedure: VATS for confirmed non-small cell lung cancer (NSCLC)<br>* Video-Assisted Thoracoscopic Surgery for NSCLC patients<br>* Other names: Video-Assisted Thoracoscopic Surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence and duration of post-operative air leak | occurrence and duration of prolonged air leak defined as longer than 5 days | prolonged air leak defined as longer than 5 days post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volume of estimated intra-operative blood loss | volume of estimated intra-operative blood loss | blood loss intra-op and up to 5 days post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC