Powered Echelon Device in VATS Surgery

• ClinicalTrials.gov Identifier: NCT01843192
• Recruitment Status: Completed
• First Posted: April 30, 2013
• Results First Posted: March 23, 2015
• Last Update Posted: June 18, 2015
• Sponsor: Ethicon Endo-Surgery
• Information provided by (Responsible Party): Ethicon Endo-Surgery

Study Description

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).

Condition or disease	Intervention/treatment
Non-small Cell Lung Cancer (NSCLC)	Device: Endocutter

Study Design

• Study Type: Observational
• Actual Enrollment: 71 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures
• Study Start Date: May 2013
• Actual Primary Completion Date: May 2014
• Actual Study Completion Date: May 2014

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Occurrence of Postoperative Air Leaks [ Time Frame: Post-operative period through hospital discharge and follow-up at Day 30 ]
   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).
2. Occurrence of Prolonged Air Leaks [ Time Frame: Post-operative period through hospital discharge and follow-up at Day 30 ]
   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).

Secondary Outcome Measures :

1. Length of Stay (LOS) [ Time Frame: Post-operative period through hospital discharge and follow-up at Day 30 ]
   Determined as the length of time in days from hospital admission to initial hospital discharge
2. Volume of Estimated Intra-operative Blood Loss [ Time Frame: Blood loss intra-op and up to 5 days post-op ]
3. Time to Chest Tube Removal [ Time Frame: Post-operative period through hospital discharge and follow-up at Day 30 ]
   Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.
4. Operative Time [ Time Frame: Day of surgery ]
   Defined as the duration in hours from the first skin incision to the closure of the last incision
5. Occurrence of Intra-operative Leak Test [ Time Frame: During surgery ]
   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.
6. Number of Subjects With 1 Chest Tube Placed [ Time Frame: During surgery ]
   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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Arizona

Dignity Health, St. Joseph's Hospital & Medical Center

Phoenix, Arizona, United States, 85013

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

United States, Missouri

Washington University School of Medicine

St. Louis, Missouri, United States, 63110

United States, Tennessee

Vanderbilt University

Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Ethicon Endo-Surgery

More Information

• Responsible Party: Ethicon Endo-Surgery
• ClinicalTrials.gov Identifier: NCT01843192
• Other Study ID Numbers: ESC-12-001
• First Posted: April 30, 2013
• Results First Posted: March 23, 2015
• Last Update Posted: June 18, 2015
• Last Verified: March 2015

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases