Non-small Cell Lung Cancer (NSCLC)
Conditions
Keywords
NSCLC
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).
Detailed description
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).
Interventions
PROCEDUREVATS for confirmed non-small cell lung cancer (NSCLC)
Video-Assisted Thoracoscopic Surgery for NSCLC patients
Sponsors
Ethicon Endo-Surgery (Europe) GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| occurrence and duration of post-operative air leak | prolonged air leak defined as longer than 5 days post-op | occurrence and duration of prolonged air leak defined as longer than 5 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| volume of estimated intra-operative blood loss | blood loss intra-op and up to 5 days post-op | volume of estimated intra-operative blood loss |
Countries
Denmark
Outcome results
None listed