Powered Echelon Device in VATS Surgery

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01843192
• Other study ID #: ESC-12-001
• Status: Completed
• Phase: N/A
• First received: April 19, 2013
• Last updated: May 21, 2015
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: March 2015
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer (NSCLC)

Intervention

Device:
• Endocutter

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Vanderbilt University	Nashville	Tennessee
United States	Dignity Health, St. Joseph's Hospital & Medical Center	Phoenix	Arizona
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Secondary	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	No
Secondary	Volume of Estimated Intra-operative Blood Loss		Blood loss intra-op and up to 5 days post-op	Yes
Secondary	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	Yes
Secondary	Operative Time	Defined as the duration in hours from the first skin incision to the closure of the last incision	Day of surgery	No
Secondary	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	Yes
Secondary	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	No