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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VATS for suspected or confirmed NSCLC | Single arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endocutter | Device |
|
| 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) 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). | 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). | Post-operative period through hospital discharge and follow-up at Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals with suspected or confirmed NSCLC, scheduled for VATS lobectomy or wedge resection in accordance with their institution's SOC
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dignity Health, St. Joseph's Hospital & Medical Center | Phoenix | Arizona | 85013 | United States | ||
| Massachusetts General Hospital |
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 |
| FG001 | Lobectomy | Subjects undergoing VATS lobectomy |
| FG002 | Wedge Resection With Lobectomy | Subjects undergoing VATS wedge resection that also required lobectomy |
| 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
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| ID | Title | Description |
|---|---|---|
| BG000 | Wedge Resection | Subjects undergoing VATS wedge resection |
| BG001 | Lobectomy | Subjects undergoing VATS lobectomy |
| 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 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). | 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 |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Schwiers | Ethicon, part of Johnson & Johnson | 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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| 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 |
| Operative Time | Defined as the duration in hours from the first skin incision to the closure of the last incision | 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. | 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. | During surgery |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| BG002 |
| Wedge Resection With Lobectomy |
Subjects undergoing VATS wedge resection that also required lobectomy |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Lobectomy | Subjects undergoing VATS lobectomy |
| OG002 | Wedge Resection With Lobectomy | Subjects undergoing VATS wedge resection that also required lobectomy |
|
|
| 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) 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). | 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 |
|
|
|
| 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 | 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 |
|
|
|
| Secondary | Operative Time | Defined as the duration in hours from the first skin incision to the closure of the last incision | 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 | hours | Day of surgery |
|
|
|
| Secondary | 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. | 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. This analysis was further restricted to those subjects in whom an intra-operative leak test was actually performed, as it was not standard of care at all participating institutions. | Posted | Number | participants | During surgery |
|
|
|
| Secondary | 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. | 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 | percentage of participants | During surgery |
|
|
|
| 2 |
| 26 |
| 8 |
| 26 |
| EG001 | Lobectomy | Subjects undergoing VATS lobectomy | 4 | 34 | 6 | 34 |
| EG002 | Wedge Resection With Lobectomy | Subjects undergoing VATS wedge resection that also required lobectomy | 2 | 11 | 3 | 11 |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary air leakage | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Vascular injury | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |