Real World Outcomes of Video-Assisted Thoracoscopic Surgery for Lung Cancer Using ECHELON FLEX™ Powered ENDOPATH® Stapler: a Prospective European Multicenter Study
| Registry | NCT01808430 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 158 (Actual) |
| Sponsor | Ethicon Endo-Surgery (Europe) GmbH (Industry) |
| Conditions | Non-small Cell Lung Cancer (NSCLC) |
| Interventions | VATS for confirmed non-small cell lung cancer (NSCLC) (Procedure) |
| Dates | start 2013-03-01, primary completion 2014-05-01, completion 2014-05-01, first posted 2013-03-11, last updated 2015-02-12 |
| Locations | 1 site in Denmark |
Related Papers Related Patents Related Grants Related Experts
All trials for Non-small Cell Lung Cancer (NSCLC) All trials of VATS for confirmed non-small cell lung cancer (NSCLC)
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).
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| VATS for NSCLC patients | Procedure: VATS for confirmed non-small cell lung cancer (NSCLC) | VATS for confirmed non-small cell lung cancer (NSCLC) |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Professor Peter Licht | Odense | Denmark |