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OpenTrials
Completed

NCT Number: NCT01843192

Powered Echelon Device in VATS Surgery

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).

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Key information

Conditions

Non-small Cell Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dignity Health, St. Joseph's Hospital & Medical Center, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endocutter

Device

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ethicon Endo-Surgery

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 30, 2013
Registry last updated
Jun 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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