Non Small Cell Lung Cancer
Conditions
Brief summary
This prospective, randomized, controlled, multi-center study will collect and compare data from the surgeon's current Standard Of Care stapler (for Pulmonary Artery/Pulmonary Vein transection) and powered vascular stapler.
Interventions
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with a confirmed or suspected diagnosis of stage IA to stage IIIA non-small cell lung cancer scheduled for a lobectomy (Lung Cancer Staging per American Joint Committee on Cancer,7th Edition)5; * Subjects scheduled for VATS lobectomy in accordance with their institution's Standard Of Care; * Performance status 0-1 (Eastern Cooperative Oncology Group classification); * American Society of Anesthesiologists (ASA) score \</= 3; * No prior history of VAT or open lung surgery (on the lung in which the procedure will be performed); * Willing to give consent and comply with study-related evaluation and treatment schedule; and * At least 18 years of age.
Exclusion criteria
* Prior chemotherapy or radiation (within 30 days prior to the procedure or the duration of the subject's enrollment); * Pregnancy; * Physical or psychological condition which would impair study participation; or * The subject is judged unsuitable for study participation by the Investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Intra-Operative Hemostatic Intervention | Intra-Operative, an average of 2.3 hours, ranging from 30 mintues to 6.4 hours | Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the Pulmonary Artery and Pulmonary Vein during Video Assisted Thoracoscopic lobectomy with the use of standard of care stapler (SOC) or powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding | Post-Op through 4 Week Followup | Incidence of hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of SOC or PVS: * Hemostasis intervention: bleeding that occurs post-operatively requiring blood or blood product transfusion or an additional surgical procedure (related to PA and PV transection). No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection). |
Countries
United States
Participant flow
Recruitment details
Recruitment was from Feb 2016 to Feb 2017 across 7 hospitals.
Pre-assignment details
229 subjects signed an informed consent, 201 were randomized into one of the two groups. The 28 not randomized did not meet the inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Facility's Current Instrumentation | 98 |
| Powered Vascular Stapler Use of the ECHELON FLEX™ Powered Vascular Stapler | 103 |
| Total | 201 |
Baseline characteristics
| Characteristic | Powered Vascular Stapler | Total | Standard of Care |
|---|---|---|---|
| Age, Continuous | 68.0 Years STANDARD_DEVIATION 9 | 68.0 Years STANDARD_DEVIATION 9 | 68.2 Years STANDARD_DEVIATION 9.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 25 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants | 136 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 20 Participants | 40 Participants | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 98 Participants | 192 Participants | 94 Participants |
| Sex: Female, Male Female | 60 Participants | 105 Participants | 45 Participants |
| Sex: Female, Male Male | 43 Participants | 96 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 96 | 0 / 105 |
| other Total, other adverse events | 35 / 96 | 33 / 105 |
| serious Total, serious adverse events | 22 / 96 | 18 / 105 |
Outcome results
Primary
Incidence of Intra-Operative Hemostatic Intervention
Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the Pulmonary Artery and Pulmonary Vein during Video Assisted Thoracoscopic lobectomy with the use of standard of care stapler (SOC) or powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open).
Time frame: Intra-Operative, an average of 2.3 hours, ranging from 30 mintues to 6.4 hours
Population: A total of 229 subjects were screened and 201 subjects were randomized into the study - 98 randomized to SOC and 103 randomized to PVS. Two subjects randomized to SOC stapler received the PVS group. These subjects are included in the stapler group for the primary endpoint analysis, consistent with the intention-to-treat principle.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Incidence of Intra-Operative Hemostatic Intervention | 0.0533 Proportion transections w/ intervention |
| Powered Vascular Stapler | Incidence of Intra-Operative Hemostatic Intervention | 0.0833 Proportion transections w/ intervention |
Secondary
Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding
Incidence of hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of SOC or PVS: * Hemostasis intervention: bleeding that occurs post-operatively requiring blood or blood product transfusion or an additional surgical procedure (related to PA and PV transection). No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection).
Time frame: Post-Op through 4 Week Followup
Population: A total of 229 subjects were screened and 201 subjects were randomized into the study - 98 randomized to SOC and 103 randomized to PVS. Two subjects randomized to SOC stapler received the PVS stapler. These subjects are included in the PVS group for safety analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding | 0.0104 Proportion participants w/ intervention |
| Powered Vascular Stapler | Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding | 0.0095 Proportion participants w/ intervention |