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CompletedNCT01843192Updated Jun 18, 2015Results posted

Powered Echelon Device in VATS Surgery

An observational study in Non-small Cell Lung Cancer (NSCLC), sponsored by Ethicon Endo-Surgery. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-18.

Sponsored by Ethicon Endo-Surgery · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
71
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Non-small Cell Lung Cancer (NSCLC)
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 71 is below the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Ethicon Endo-Surgery is the lead sponsor of 47 studies on the registry; 1 is open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
71 participants (actual)
Patient registry
No

Groups and cohorts

  • VATS for suspected or confirmed NSCLC

    Single arm study

    Device: Endocutter

Interventions

  • DeviceEndocutter
06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Post-operative period through hospital discharge and follow-up at Day 30

  2. 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).

    Time frame: Post-operative period through hospital discharge and follow-up at Day 30

Secondary outcomes

  1. Length of Stay (LOS)

    Determined as the length of time in days from hospital admission to initial hospital discharge

    Time frame: Post-operative period through hospital discharge and follow-up at Day 30

  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

    Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.

    Time frame: Post-operative period through hospital discharge and follow-up at Day 30

  4. Operative Time

    Defined as the duration in hours from the first skin incision to the closure of the last incision

    Time frame: Day of surgery

  5. 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.

    Time frame: During surgery

  6. 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.

    Time frame: During surgery

07

Results

Posted Mar 23, 2015

Participant flow

Individuals undergoing VATS lobectomy for suspected or confirmed Non-small Cell Lung Cancer, or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of Care, and who meet study entry criteria, were enrolled in this study.

Participant flow — Overall Study
MilestoneWedge ResectionLobectomyWedge Resection With Lobectomy
Started263411
Completed24289
Not completed262
Withdrew: Intra-operative exclusions per protocol262

Outcome measures

PrimaryOccurrence 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).

Time frame:
Post-operative period through hospital discharge and follow-up at Day 30
Reported as:
Number · percentage of participants
Occurrence of Postoperative Air Leaks
percentage of participantsWedge ResectionLobectomyWedge Resection With Lobectomy
Occurrence of Postoperative Air Leaks45.8 (25.6 to 67.2)67.9 (47.6 to 84.1)88.9 (51.8 to 99.7)
PrimaryOccurrence 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).

Time frame:
Post-operative period through hospital discharge and follow-up at Day 30
Reported as:
Number · percentage of participants
Occurrence of Prolonged Air Leaks
percentage of participantsWedge ResectionLobectomyWedge Resection With Lobectomy
Occurrence of Prolonged Air Leaks4.2 (0.1 to 21.1)7.1 (0.9 to 23.5)22.2 (2.8 to 60)
SecondaryLength of Stay (LOS)

Determined as the length of time in days from hospital admission to initial hospital discharge

Time frame:
Post-operative period through hospital discharge and follow-up at Day 30
Reported as:
Mean · days
Length of Stay (LOS)
daysWedge ResectionLobectomyWedge Resection With Lobectomy
Length of Stay (LOS)3.7 ± 1.634.9 ± 1.704.8 ± 1.48
SecondaryVolume of Estimated Intra-operative Blood Loss
Time frame:
Blood loss intra-op and up to 5 days post-op
Reported as:
Mean · milliliters
Volume of Estimated Intra-operative Blood Loss
millilitersWedge ResectionLobectomyWedge Resection With Lobectomy
Volume of Estimated Intra-operative Blood Loss31.5 ± 56.4883.2 ± 62.4286.1 ± 80.15
SecondaryTime 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.

Time frame:
Post-operative period through hospital discharge and follow-up at Day 30
Reported as:
Mean · days
Time to Chest Tube Removal
daysWedge ResectionLobectomyWedge Resection With Lobectomy
Time to Chest Tube Removal3.7 ± 1.634.9 ± 1.74.8 ± 1.48
SecondaryOperative Time

Defined as the duration in hours from the first skin incision to the closure of the last incision

Time frame:
Day of surgery
Reported as:
Mean · hours
Operative Time
hoursWedge ResectionLobectomyWedge Resection With Lobectomy
Operative Time1.7 ± 0.682.8 ± 0.853.4 ± 1.43
SecondaryOccurrence 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.

Time frame:
During surgery
Reported as:
Number · participants
Occurrence of Intra-operative Leak Test
participantsWedge ResectionLobectomyWedge Resection With Lobectomy
Occurrence of Intra-operative Leak Test001
SecondaryNumber 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.

Time frame:
During surgery
Reported as:
Number · percentage of participants
Number of Subjects With 1 Chest Tube Placed
percentage of participantsWedge ResectionLobectomyWedge Resection With Lobectomy
Number of Subjects With 1 Chest Tube Placed88.510088.9

Adverse events

Collected over Duration of follow-up was scheduled through approximately 4 weeks post surgery. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Wedge Resection—2/26 (7.7%)8/26 (30.8%)
Lobectomy—4/34 (11.8%)6/34 (17.6%)
Wedge Resection With Lobectomy—2/11 (18.2%)3/11 (27.3%)
Most frequent serious events
Most frequent serious events
EventWedge ResectionLobectomyWedge Resection With Lobectomy
Pulmonary air leakageRespiratory, thoracic and mediastinal disorders1/261/342/11
ChylothoraxRespiratory, thoracic and mediastinal disorders1/260/340/11
Atrial fibrillationCardiac disorders0/261/340/11
PneumothoraxRespiratory, thoracic and mediastinal disorders0/261/340/11
HaemorrhageVascular disorders0/261/340/11
Most frequent other events
Showing 10 of 13
Most frequent other events
EventWedge ResectionLobectomyWedge Resection With Lobectomy
Subcutaneous emphysemaSkin and subcutaneous tissue disorders1/262/342/11
NauseaGastrointestinal disorders1/260/341/11
HeadacheNervous system disorders0/260/341/11
Vascular injuryInjury, poisoning and procedural complications0/262/340/11
Corneal abrasionInjury, poisoning and procedural complications1/260/340/11
Urinary tract infectionInfections and infestations1/261/340/11
CellulitisInfections and infestations1/260/340/11
Atrial fibrillationCardiac disorders1/261/340/11
Supraventricular extrasystolesCardiac disorders1/260/340/11
VomitingGastrointestinal disorders1/260/340/11

Baseline characteristics

All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure

Age, Continuous
Age, Continuous(years)Wedge ResectionLobectomyWedge Resection With LobectomyTotal
Mean63.3 ± 10.0268.1 ± 7.2668.7 ± 5.7266.3 ± 8.51
Sex: Female, Male
Sex: Female, Male(Participants)Wedge ResectionLobectomyWedge Resection With LobectomyTotal
Female1220537
Male128424
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Wedge ResectionLobectomyWedge Resection With LobectomyTotal
Hispanic or Latino0000
Not Hispanic or Latino2428961
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Wedge ResectionLobectomyWedge Resection With LobectomyTotal
American Indian or Alaska Native0000
Asian0101
Native Hawaiian or Other Pacific Islander0000
Black or African American1001
White2327959
More than one race0000
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)Wedge ResectionLobectomyWedge Resection With LobectomyTotal
United States2428961
08

Study locations

4 sites
  • Dignity Health, St. Joseph's Hospital & Medical Center
    Phoenix, Arizona 85013, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Washington University School of Medicine
    St. Louis, Missouri 63110, United States
  • Vanderbilt University
    Nashville, Tennessee 37232, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01843192
Lead sponsor
Ethicon Endo-Surgery
Responsible party
Sponsor
First posted
Apr 30, 2013
Start date
May 2013
Primary completion
May 2014
Completion
May 2014
Results posted
Mar 23, 2015
Last update
Jun 18, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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