Real World Outcomes of Video-Assisted Thoracoscopic Surgery for Lung Cancer Using ECHELON FLEX™ Powered ENDOPATH® Stapler: a Prospective European Multicenter Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 158
- Locations
- 1
- Primary Endpoint
- occurrence and duration of post-operative air leak
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
occurrence and duration of post-operative air leak
Time Frame: 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 Outcomes
- volume of estimated intra-operative blood loss(blood loss intra-op and up to 5 days post-op)