Clinical trial NCT01843192: Powered Echelon Device in VATS Surgery
Official title: A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer (NSCLC)
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2013-04-30
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with suspected or confirmed NSCLC, scheduled for VATS lobectomy or wedge resection in accordance with their institution's SOC

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).


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

Primary outcomes:
measure: Occurrence of Postoperative Air Leaks
timeFrame: Post-operative period through hospital discharge and follow-up at Day 30
measure: Occurrence of Prolonged Air Leaks
timeFrame: Post-operative period through hospital discharge and follow-up at Day 30
Secondary outcomes:
measure: Length of Stay (LOS)
timeFrame: Post-operative period through hospital discharge and follow-up at Day 30
measure: Volume of Estimated Intra-operative Blood Loss
timeFrame: Blood loss intra-op and up to 5 days post-op
measure: Time to Chest Tube Removal
timeFrame: Post-operative period through hospital discharge and follow-up at Day 30
measure: Operative Time
timeFrame: Day of surgery
measure: Occurrence of Intra-operative Leak Test
timeFrame: During surgery
measure: Number of Subjects With 1 Chest Tube Placed
timeFrame: During surgery
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Dignity Health, St. Joseph's Hospital & Medical Center
state: Arizona
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
References: