Non-small Cell Lung Cancer (NSCLC)
Conditions
Brief 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).
Interventions
DEVICEEndocutter
Sponsors
Ethicon Endo-Surgery
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Postoperative Air Leaks | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Chest Tube Removal | Post-operative period through hospital discharge and follow-up at Day 30 | Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure. |
| Operative Time | Day of surgery | Defined as the duration in hours from the first skin incision to the closure of the last incision |
| Length of Stay (LOS) | Post-operative period through hospital discharge and follow-up at Day 30 | Determined as the length of time in days from hospital admission to initial hospital discharge |
| Number of Subjects With 1 Chest Tube Placed | During surgery | 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. |
| Occurrence of Intra-operative Leak Test | During surgery | 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. |
| Volume of Estimated Intra-operative Blood Loss | Blood loss intra-op and up to 5 days post-op | — |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Wedge Resection Subjects undergoing VATS wedge resection | 24 |
| Lobectomy Subjects undergoing VATS lobectomy | 28 |
| Wedge Resection With Lobectomy Subjects undergoing VATS wedge resection that also required lobectomy | 9 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Intra-operative exclusions per protocol | 2 | 6 | 2 |
Baseline characteristics
| Characteristic | Wedge Resection | Total | Wedge Resection With Lobectomy | Lobectomy |
|---|---|---|---|---|
| Age, Continuous | 63.3 years STANDARD_DEVIATION 10.02 | 66.3 years STANDARD_DEVIATION 8.51 | 68.7 years STANDARD_DEVIATION 5.72 | 68.1 years STANDARD_DEVIATION 7.26 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 61 Participants | 9 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 59 Participants | 9 Participants | 27 Participants |
| Region of Enrollment United States | 24 participants | 61 participants | 9 participants | 28 participants |
| Sex: Female, Male Female | 12 Participants | 37 Participants | 5 Participants | 20 Participants |
| Sex: Female, Male Male | 12 Participants | 24 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 26 | 6 / 34 | 3 / 11 |
| serious Total, serious adverse events | 2 / 26 | 4 / 34 | 2 / 11 |
Outcome results
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).
Time frame: Post-operative period through hospital discharge and follow-up at Day 30
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Wedge Resection | Occurrence of Postoperative Air Leaks | 45.8 percentage of participants |
| Lobectomy | Occurrence of Postoperative Air Leaks | 67.9 percentage of participants |
| Wedge Resection With Lobectomy | Occurrence of Postoperative Air Leaks | 88.9 percentage of participants |
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).
Time frame: Post-operative period through hospital discharge and follow-up at Day 30
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Wedge Resection | Occurrence of Prolonged Air Leaks | 4.2 percentage of participants |
| Lobectomy | Occurrence of Prolonged Air Leaks | 7.1 percentage of participants |
| Wedge Resection With Lobectomy | Occurrence of Prolonged Air Leaks | 22.2 percentage of participants |
Secondary
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
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wedge Resection | Length of Stay (LOS) | 3.7 days | Standard Deviation 1.63 |
| Lobectomy | Length of Stay (LOS) | 4.9 days | Standard Deviation 1.7 |
| Wedge Resection With Lobectomy | Length of Stay (LOS) | 4.8 days | Standard Deviation 1.48 |
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.
Time frame: During surgery
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Wedge Resection | Number of Subjects With 1 Chest Tube Placed | 88.5 percentage of participants |
| Lobectomy | Number of Subjects With 1 Chest Tube Placed | 100 percentage of participants |
| Wedge Resection With Lobectomy | Number of Subjects With 1 Chest Tube Placed | 88.9 percentage of participants |
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.
Time frame: During surgery
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Wedge Resection | Occurrence of Intra-operative Leak Test | 0 participants |
| Lobectomy | Occurrence of Intra-operative Leak Test | 0 participants |
| Wedge Resection With Lobectomy | Occurrence of Intra-operative Leak Test | 1 participants |
Secondary
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
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wedge Resection | Operative Time | 1.7 hours | Standard Deviation 0.68 |
| Lobectomy | Operative Time | 2.8 hours | Standard Deviation 0.85 |
| Wedge Resection With Lobectomy | Operative Time | 3.4 hours | Standard Deviation 1.43 |
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.
Time frame: Post-operative period through hospital discharge and follow-up at Day 30
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wedge Resection | Time to Chest Tube Removal | 3.7 days | Standard Deviation 1.63 |
| Lobectomy | Time to Chest Tube Removal | 4.9 days | Standard Deviation 1.7 |
| Wedge Resection With Lobectomy | Time to Chest Tube Removal | 4.8 days | Standard Deviation 1.48 |
Secondary
Volume of Estimated Intra-operative Blood Loss
Time frame: Blood loss intra-op and up to 5 days post-op
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wedge Resection | Volume of Estimated Intra-operative Blood Loss | 31.5 milliliters | Standard Deviation 56.48 |
| Lobectomy | Volume of Estimated Intra-operative Blood Loss | 83.2 milliliters | Standard Deviation 62.42 |
| Wedge Resection With Lobectomy | Volume of Estimated Intra-operative Blood Loss | 86.1 milliliters | Standard Deviation 80.15 |