N/A
N=105
Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in Korea
Non-small Cell Lung Cancer (NSCLC)
Bottom Line
View on ClinicalTrials.gov: NCT02196675 ↗Enrolled (actual)
105
Serious AEs
11.4%
Results posted
Dec 2015
Primary outcome: Primary: Occurrence of Prolonged Air Leaks — 0.0; 5.8; 37.5 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Endocutter (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Ethicon Endo-Surgery
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Prolonged Air Leaks |
0.0; 5.8; 37.5 | — |
| SECONDARY Occurrence of Postoperative Air Leaks |
30.8; 42.0; 75.0 | — |
| SECONDARY Length of Stay (LOS) |
7.2; 9.3; 9.4 | — |
| SECONDARY Volume of Estimated Intra-operative Blood Loss |
30.4; 146.1; 91.3 | — |
| SECONDARY Time to Chest Tube Removal |
3.4; 5.2; 6.3 | — |
Summary
Collection of 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) in a Korean population.
Eligibility Criteria
Inclusion Criteria
- Suspected or confirmed of NSCLC (up to and including Stage II), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC);
- 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; and
- At least 19 years of age.
Exclusion Criteria
- Active (subject currently receiving systemic treatment) bacterial infection or fungal infection;
- Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain 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 (NCT02196675). 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.