N/A
N=71
Powered Echelon Device in VATS Surgery
Non-small Cell Lung Cancer (NSCLC)
Bottom Line
View on ClinicalTrials.gov: NCT01843192 ↗Enrolled (actual)
71
Serious AEs
11.3%
Results posted
Mar 2015
Primary outcome: Primary: Occurrence of Postoperative Air Leaks — 45.8; 67.9; 88.9 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Endocutter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ethicon Endo-Surgery
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Postoperative Air Leaks |
45.8; 67.9; 88.9 | — |
| PRIMARY Occurrence of Prolonged Air Leaks |
4.2; 7.1; 22.2 | — |
| SECONDARY Length of Stay (LOS) |
3.7; 4.9; 4.8 | — |
| SECONDARY Volume of Estimated Intra-operative Blood Loss |
31.5; 83.2; 86.1 | — |
| SECONDARY Time to Chest Tube Removal |
3.7; 4.9; 4.8 | — |
| SECONDARY Operative Time |
1.7; 2.8; 3.4 | — |
| SECONDARY Occurrence of Intra-operative Leak Test |
0; 0; 1 | — |
| SECONDARY Number of Subjects With 1 Chest Tube Placed |
88.5; 100; 88.9 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Suspected or confirmed NSCLC (up to and including Stage II)
- 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
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)
- 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
Data sourced from ClinicalTrials.gov (NCT01843192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.