Non-small Cell Lung Cancer (NSCLC)NCT02196675

Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in Korea

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

Completed

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

Trial summary

Collection of 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) in a Korean population. Read more about this study

Who is it for?: Ages 19 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: 105 participants
Where: 4 sitesSouth Korea
Study dates: Jul 2014to Jan 2015
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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Individuals with suspected or confirmed of NSCLC (up to and including Stage II), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC);

Who may be able to join

Suspected or confirmed of NSCLC (up to and including Stage II), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC);
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; and
At least 19 years of age.

Who cannot join

Active (subject currently receiving systemic treatment) bacterial infection or fungal infection;
Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain 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.

South Korea4 sites

National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
Samsung Medical Center
Seoul, Seoul, 135-710
Asan Medical Center
Seoul, Seoul, 138-736
Korean University Guro Hospital
Seoul, Seoul, 152-703

Other trials in South Korea

About this study

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

Read the detailed description

This clinical trial assessed the use of a powered stapler for transection in VATS lung resection, where there is currently limited published clinical data. The primary study endpoint was occurrence and duration of air leak / prolonged air leak (PAL). Procedure details and perioperative outcomes associated with VATS lung resections were also evaluated.

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
The study utilized Echelon FlexTM Powered ENDOPATH® Stapler (Ethicon, Cincinnati, USA) along with compatible cartridges: Gray (closed staple height, 0.75mm), White (1.0mm), Blue (1.5mm), Gold (1.8mm), Green (2.0mm), and Black (2.3mm).

Study groups in NCT02196675
Study group	Role	What they receive
VATS wedge resection or lobectomy		Single arm study Intervention: Device: Endocutter Receives: Device: Endocutter

What is being measured

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

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). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).
Measured: Post-operative period through hospital discharge and follow-up at Day 30

Secondary outcomes (4)

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). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).
Measured: Post-operative period through hospital discharge and follow-up at Day 30
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

Timeline

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

Jul 2014Jan 2015

First posted22 Jul 2014 (estimated)
Study startJul 2014
Primary completionJan 2015
Study completionJan 2015

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: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02196675
Sponsor's protocol ID: ESC-13-003
Status last verified: Jun 2016
First submitted: 19 Jul 2014
Last updated: 15 Jul 2016
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 15 Jul 2016. 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 in Korea
ClinicalTrials.gov ID: NCT02196675
Acronym / sponsor ID: ESC-13-003
Conditions: Non-small Cell Lung Cancer (NSCLC)
Study type: Observational
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 22 Jul 2014 (estimated)
Results: Posted 18 Dec 2015

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
VATS wedge resection or lobectomy	–	Device: EndocutterSingle arm study Intervention: Device: Endocutter

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Individuals with suspected or confirmed of NSCLC (up to and including Stage II), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC);

Key inclusion criteria (7 listed)

Suspected or confirmed of NSCLC (up to and including Stage II), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC);
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 (subject currently receiving systemic treatment) bacterial infection or fungal infection;
Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain 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
EndocutterThe study utilized Echelon FlexTM Powered ENDOPATH® Stapler (Ethicon, Cincinnati, USA) along with compatible cartridges: Gray (closed staple height, 0.75mm), White (1.0mm), Blue (1.5mm), Gold (1.8mm), Green (2.0mm), and Black (2.3mm).	Device	VATS wedge resection or lobectomy

Primary outcome

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). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).

4 secondary outcomes

Occurrence of Postoperative Air Leaks
Time frame: Post-operative period through hospital discharge and follow-up at Day 30
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

Results and safety

Results posted to the registry on 18 Dec 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	27	25
Lobectomy	70	68
Wedge Resection With Lobectomy	8	7

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 = 26	Lobectomy n = 69	Wedge Resection With Lobectomy n = 8
Value	0.0 (0.0 to 13.2)	5.8 (1.6 to 14.2)	37.5 (8.5 to 75.5)

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

4 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 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Wedge Resection	0 of 27 (0%)	17 of 27 (63%)	Not reported
Lobectomy	9 of 70 (12.9%)	43 of 70 (61.4%)	Not reported
Wedge Resection With Lobectomy	3 of 8 (37.5%)	7 of 8 (87.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Non-small Cell Lung Cancer (NSCLC)

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
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Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
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Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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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.

Elliott Fegelman, MD study director

Johnson & Johson

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 South Korea.

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 7 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 15 Jul 2016. 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 South Korea. 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 18 Dec 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 Prolonged Air Leaks (time frame: Post-operative period through hospital discharge and follow-up at Day 30). 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 NCT02196675.

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 15 Jul 2016; AzTrials last refreshed its copy on 7 Nov 2026.