Non-small Cell Lung Cancer (NSCLC)NCT01843192

Powered Echelon Device in VATS Surgery

An observational study of Non-small Cell Lung Cancer (NSCLC), run by Ethicon Endo-Surgery at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-small Cell Lung Cancer (NSCLC)
What is being tested?: Endocutter
Type of treatment: Medical device
How many people: 71 participants
Where: 4 sitesUnited States
Study dates: May 2013to May 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Individuals with suspected or confirmed NSCLC, scheduled for VATS lobectomy or wedge resection in accordance with their institution's SOC

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

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

Other trials in United States

About this study

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

Conditions: Non-small Cell Lung Cancer (NSCLC)
Being tested: Endocutter
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EndocutterDevice

Study groups in NCT01843192
Study group	Role	What they receive
VATS for suspected or confirmed NSCLC		Single arm study Receives: Device: Endocutter

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: Post-operative period through hospital discharge and follow-up at Day 30

Secondary outcomes (6)

Length of Stay (LOS)
Determined as the length of time in days from hospital admission to initial hospital discharge
Measured: Post-operative period through hospital discharge and follow-up at Day 30
Volume of Estimated Intra-operative Blood Loss
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: During surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013May 2014

First posted30 Apr 2013 (estimated)
Study startMay 2013
Primary completionMay 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01843192
Sponsor's protocol ID: ESC-12-001
Status last verified: Mar 2015
First submitted: 19 Apr 2013
Last updated: 18 Jun 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Non-small Cell Lung Cancer (NSCLC) trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures
ClinicalTrials.gov ID: NCT01843192
Acronym / sponsor ID: ESC-12-001
Conditions: Non-small Cell Lung Cancer (NSCLC)
Study type: Observational
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
Study start: May 2013
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 30 Apr 2013 (estimated)
Results: Posted 23 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
VATS for suspected or confirmed NSCLC	–	Device: EndocutterSingle arm study

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Individuals with suspected or confirmed NSCLC, scheduled for VATS lobectomy or wedge resection in accordance with their institution's SOC

Key inclusion criteria (6 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Endocutter	Device	VATS for suspected or confirmed NSCLC

Primary outcome

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).
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).

6 secondary outcomes

Length of Stay (LOS)
Time frame: Post-operative period through hospital discharge and follow-up at Day 30
Volume of Estimated Intra-operative Blood Loss
Time frame: Blood loss intra-op and up to 5 days post-op
Time to Chest Tube Removal
Time frame: Post-operative period through hospital discharge and follow-up at Day 30
Operative Time
Time frame: Day of surgery
Occurrence of Intra-operative Leak Test
Time frame: During surgery
Number of Subjects With 1 Chest Tube Placed
Time frame: During surgery

Results and safety

Results posted to the registry on 23 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Wedge Resection	26	24
Lobectomy	34	28
Wedge Resection With Lobectomy	11	9

Primary outcome: Occurrence of Postoperative Air Leaks

Time frame: Post-operative period through hospital discharge and follow-up at Day 30. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Wedge Resection n = 24	Lobectomy n = 28	Wedge Resection With Lobectomy n = 9
Value	45.8 (25.6 to 67.2)	67.9 (47.6 to 84.1)	88.9 (51.8 to 99.7)

Population analysed: 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

Primary outcome: Occurrence of Prolonged Air Leaks

Time frame: Post-operative period through hospital discharge and follow-up at Day 30. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Wedge Resection n = 24	Lobectomy n = 28	Wedge Resection With Lobectomy n = 9
Value	4.2 (0.1 to 21.1)	7.1 (0.9 to 23.5)	22.2 (2.8 to 60)

Population analysed: 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

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Duration of follow-up was scheduled through approximately 4 weeks post surgery. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Wedge Resection	2 of 26 (7.7%)	8 of 26 (30.8%)	Not reported
Lobectomy	4 of 34 (11.8%)	6 of 34 (17.6%)	Not reported
Wedge Resection With Lobectomy	2 of 11 (18.2%)	3 of 11 (27.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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A Clinical Study to Assess the Efficacy of Adjuvant Immunotherapy With Cemiplimab in Patients With Surgically Removed Non-small Cell Lung Cancer Who Have Not Received Prior Chemotherapy
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RecruitingPhase 2
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
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Master Protocol for the Study of Rilogrotug for the Treatment of Weight Loss and Anorexia in Patients With Cancer Cachexia and mCRC or mNSCLC
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Non-small Cell Lung Cancer (NSCLC), run by Ethicon Endo-Surgery at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Postoperative Air Leaks (time frame: Post-operative period through hospital discharge and follow-up at Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01843192.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2015.