Powered Echelon Device in VATS Surgery

A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures

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).

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Device: Endocutter

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Dignity Health, St. Joseph's Hospital & Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VATS for suspected or confirmed NSCLC; Single arm study	Device: Endocutter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Postoperative Air Leaks	Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers).	Post-operative period through hospital discharge and follow-up at Day 30
Occurrence of Prolonged Air Leaks	Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers).	Post-operative period through hospital discharge and follow-up at Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay (LOS)	Determined as the length of time in days from hospital admission to initial hospital discharge	Post-operative period through hospital discharge and follow-up at Day 30
Volume of Estimated Intra-operative Blood Loss		Blood loss intra-op and up to 5 days post-op
Time to Chest Tube Removal	Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.	Post-operative period through hospital discharge and follow-up at Day 30
Operative Time	Defined as the duration in hours from the first skin incision to the closure of the last incision	Day of surgery
Occurrence of Intra-operative Leak Test	This outcome was scored as Yes or No based on whether a leak was detected during an intra-operative leak test when it was performed. Not all subjects had an intra-operative leak test performed, as it was not standard of care at all participating institutions, and so results are only presented for those subjects in whom an intra-operative test was performed.	During surgery
Number of Subjects With 1 Chest Tube Placed	All subjects had either 1 or 2 chest tubes placed during surgery. Results presented are for the percentage of subjects with 1 chest tube placed.	During surgery

Collaborators and Investigators

• Sponsor: Ethicon Endo-Surgery

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: April 19, 2013
• First Submitted That Met QC Criteria: April 26, 2013
• First Posted (Estimate): April 30, 2013

Study Record Updates

• Last Update Posted (Estimate): June 18, 2015
• Last Update Submitted That Met QC Criteria: May 21, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: ESC-12-001