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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VATS wedge resection or lobectomy | Single arm study Intervention: Device: Endocutter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endocutter | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Post-operative period through hospital discharge and follow-up at Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Post-operative period through hospital discharge and follow-up at Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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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);
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| Name | Affiliation | Role |
|---|---|---|
| Elliott Fegelman, MD | Johnson & Johson | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Goyang-si | Gyeonggi-do | 410-769 | South Korea | ||
| Samsung Medical Center |
There was no assignment to treatment group given that this is a single arm study wherein the same device was used on all subjects. Results are presented for the overall cohort as well as by the individual procedure performed - lobectomy, wedge resection, or wedge resection with lobectomy.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Wedge Resection | Subjects undergoing VATS wedge resection using Echelon FlexTM Powered ENDOPATH® Stapler |
| FG001 | Lobectomy | Subjects undergoing VATS lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler |
| FG002 | Wedge Resection With Lobectomy | Subjects undergoing VATS wedge resection that also required lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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. Two enrolled subjects were converted to an open procedure and thus were not included in this summary. These subjects were followed for safety.
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| ID | Title | Description |
|---|---|---|
| BG000 | Wedge Resection | Subjects undergoing VATS wedge resection using Echelon FlexTM Powered ENDOPATH® Stapler |
| BG001 | Lobectomy | Subjects undergoing VATS lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). | 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 | Posted | Number | 95% Confidence Interval | percentage of participants | Post-operative period through hospital discharge and follow-up at Day 30 |
|
Duration of follow-up was scheduled through approximately 4 weeks post surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Wedge Resection | Subjects undergoing VATS wedge resection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Schwiers, Principal Biostatistician | Ethicon | 513-337-1172 | mschwier@its.jnj.com |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| 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 |
| Volume of Estimated Intra-operative Blood Loss | 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. | Post-operative period through hospital discharge and follow-up at Day 30 |
| Seoul |
| Seoul |
| 135-710 |
| South Korea |
| Asan Medical Center | Seoul | Seoul | 138-736 | South Korea |
| Korean University Guro Hospital | Seoul | Seoul | 152-703 | South Korea |
| Protocol Violation |
|
| Death |
|
| BG002 | Wedge Resection With Lobectomy | Subjects undergoing VATS wedge resection that also required lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Lobectomy |
Subjects undergoing VATS lobectomy |
| OG002 | Wedge Resection With Lobectomy | Subjects undergoing VATS wedge resection that also required lobectomy |
|
|
| Secondary | 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). | ll 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 | Posted | Number | 95% Confidence Interval | percentage of participants | Post-operative period through hospital discharge and follow-up at Day 30 |
|
|
|
| Secondary | Length of Stay (LOS) | Determined as the length of time in days from hospital admission to initial hospital discharge | 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 and had complete data. One subject was missing the hospital discharge date, thus length of stay could not be calculated. | Posted | Mean | Standard Deviation | days | Post-operative period through hospital discharge and follow-up at Day 30 |
|
|
|
| Secondary | Volume of Estimated Intra-operative Blood Loss | 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 | Posted | Mean | Standard Deviation | milliliters | Blood loss intra-op and up to 5 days post-op |
|
|
|
| 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. | 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 | Posted | Mean | Standard Deviation | days | Post-operative period through hospital discharge and follow-up at Day 30 |
|
|
|
| 0 |
| 27 |
| 17 |
| 27 |
| EG001 | Lobectomy | Subjects undergoing VATS lobectomy | 9 | 70 | 43 | 70 |
| EG002 | Wedge Resection With Lobectomy | Subjects undergoing VATS wedge resection that also required lobectomy | 3 | 8 | 7 | 8 |
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Vocal cord paralysis | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pulmonary air leakage | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA (12.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
Prior to submission for publication or presentation, the Institution will provide Sponsor with at least sixty (60) days for review of a manuscript. Notwithstanding the foregoing, no paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written consent.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |