Non-small Cell Lung Cancer (NSCLC)
Conditions
Brief 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.
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.
Interventions
DEVICEEndocutter
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).
Sponsors
Ethicon Endo-Surgery
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). |
Secondary
| 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). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). |
| 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 |
| Volume of Estimated Intra-operative Blood Loss | Blood loss intra-op and up to 5 days post-op | — |
| 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. |
Countries
South Korea
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 using Echelon FlexTM Powered ENDOPATH® Stapler | 26 |
| Lobectomy Subjects undergoing VATS lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler | 69 |
| Wedge Resection With Lobectomy Subjects undergoing VATS wedge resection that also required lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler | 8 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 |
| Overall Study | Intra-operative surgical exclusion | 1 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Wedge Resection | Total | Wedge Resection With Lobectomy | Lobectomy |
|---|---|---|---|---|
| Age, Continuous | 62.8 years STANDARD_DEVIATION 11.39 | 61.2 years STANDARD_DEVIATION 10.47 | 61.6 years STANDARD_DEVIATION 8.09 | 60.5 years STANDARD_DEVIATION 10.41 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 26 Participants | 103 Participants | 8 Participants | 69 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Korea, Republic of | 26 participants | 103 participants | 8 participants | 69 participants |
| Sex: Female, Male Female | 13 Participants | 49 Participants | 5 Participants | 31 Participants |
| Sex: Female, Male Male | 13 Participants | 54 Participants | 3 Participants | 38 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 | 17 / 27 | 43 / 70 | 7 / 8 |
| serious Total, serious adverse events | 0 / 27 | 9 / 70 | 3 / 8 |
Outcome results
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).
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 | 0.0 percentage of participants |
| Lobectomy | Occurrence of Prolonged Air Leaks | 5.8 percentage of participants |
| Wedge Resection With Lobectomy | Occurrence of Prolonged Air Leaks | 37.5 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 and had complete data. One subject was missing the hospital discharge date, thus length of stay could not be calculated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wedge Resection | Length of Stay (LOS) | 7.2 days | Standard Deviation 2.95 |
| Lobectomy | Length of Stay (LOS) | 9.3 days | Standard Deviation 4.07 |
| Wedge Resection With Lobectomy | Length of Stay (LOS) | 9.4 days | Standard Deviation 2.67 |
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).
Time frame: Post-operative period through hospital discharge and follow-up at Day 30
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Wedge Resection | Occurrence of Postoperative Air Leaks | 30.8 percentage of participants |
| Lobectomy | Occurrence of Postoperative Air Leaks | 42.0 percentage of participants |
| Wedge Resection With Lobectomy | Occurrence of Postoperative Air Leaks | 75.0 percentage of participants |
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 | 3.4 days | Standard Deviation 1.63 |
| Lobectomy | Time to Chest Tube Removal | 5.2 days | Standard Deviation 1.97 |
| Wedge Resection With Lobectomy | Time to Chest Tube Removal | 6.3 days | Standard Deviation 2.38 |
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 | 30.4 milliliters | Standard Deviation 40.27 |
| Lobectomy | Volume of Estimated Intra-operative Blood Loss | 146.1 milliliters | Standard Deviation 155.96 |
| Wedge Resection With Lobectomy | Volume of Estimated Intra-operative Blood Loss | 91.3 milliliters | Standard Deviation 124.95 |