Trial Outcomes & Findings for Study Comparing Two Types of Ports in Patients With Cancer Receiving Intravenous Chemotherapy (NCT NCT00607880)
NCT ID: NCT00607880
Last Updated: 2014-05-09
Results Overview
We report the proportion of patients in each treatment group who have some degree of port failure. Port failure is defined as the composite outcome of port malfunction due to partial or total occlusion and any infection related to the port, within 12 months of port insertion. The percentages reported here are the number of patients that had reported a port failure within 12 months out of the number of patients with port failure within 12 months plus the number of patients that were followed 12 months without port failure.
COMPLETED
PHASE2
100 participants
Up to 12 months from port insertion
2014-05-09
Participant Flow
All patients considered for port implantation for intravenous chemotherapy were consulted and evaluated for port implantation. This evaluation was not study specific. If the implantation of a port system was feasible, the patient fulfilled inclusion criteria and the patient consented to the study, then they were randomly assigned a treatment port.
One patient in the Standard Access Port group was unable to have the port placed due to chronic left internal jugular occlusion and was excluded from the analyses.
Participant milestones
| Measure |
Standard Access Port
Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
|
Vortex Implantable Access Port
Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
49
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Standard Access Port
Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
|
Vortex Implantable Access Port
Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
|
|---|---|---|
|
Overall Study
Unable to place port due to occlusion
|
1
|
0
|
Baseline Characteristics
Study Comparing Two Types of Ports in Patients With Cancer Receiving Intravenous Chemotherapy
Baseline characteristics by cohort
| Measure |
Standard Access Port
n=50 Participants
Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
|
Vortex Implantable Access Port
n=50 Participants
Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=99 Participants
|
64 years
n=107 Participants
|
65 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
50 participants
n=107 Participants
|
100 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months from port insertionPopulation: Patients with port failure within 12 months and patients that were followed 12 months without port failure were included in this analysis.
We report the proportion of patients in each treatment group who have some degree of port failure. Port failure is defined as the composite outcome of port malfunction due to partial or total occlusion and any infection related to the port, within 12 months of port insertion. The percentages reported here are the number of patients that had reported a port failure within 12 months out of the number of patients with port failure within 12 months plus the number of patients that were followed 12 months without port failure.
Outcome measures
| Measure |
Standard Access Port
n=31 Participants
Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
|
Vortex Implantable Access Port
n=29 Participants
Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
|
|---|---|---|
|
Port Failure Within 12 Months of Port Insertion
|
16.1 percentage of patients
Interval 3.2 to 29.0
|
13.8 percentage of patients
Interval 1.2 to 26.4
|
SECONDARY outcome
Timeframe: Up to 12 months after port insertionNumber of patients that died during treatment due to any cause.
Outcome measures
| Measure |
Standard Access Port
n=49 Participants
Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
|
Vortex Implantable Access Port
n=50 Participants
Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
|
|---|---|---|
|
Death From All Causes
|
9 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Up to 12 months after port insertionPopulation: All patients accrued to this study that had their port removed within12 months for any reason other than infection/occlusion were included in this analysis. 28 patients using the Standard Access Port and 30 patients using the Vortex Implantable Access Port had port removal prior to 12 months due to reasons other than infection or occlusion..
We report the number of patients that terminated use of port due to any reason other than infection or occlusion within 12 months.
Outcome measures
| Measure |
Standard Access Port
n=28 Participants
Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
|
Vortex Implantable Access Port
n=30 Participants
Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
|
|---|---|---|
|
Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion
Thrombosis
|
0 participants
|
1 participants
|
|
Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion
Death
|
9 participants
|
6 participants
|
|
Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion
End of Chemotherapy
|
7 participants
|
6 participants
|
|
Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion
Skin Erosion
|
1 participants
|
0 participants
|
|
Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion
Unhealed Incision
|
1 participants
|
0 participants
|
|
Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion
Patient Moved/Transferred Care
|
4 participants
|
7 participants
|
|
Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion
Patient Request
|
1 participants
|
0 participants
|
|
Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion
Unknown
|
5 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Up to 12 months after port insertionThe number of patients that discontinued use of inserted port for any reason at the 12 month timepoint.
Outcome measures
| Measure |
Standard Access Port
n=49 Participants
Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
|
Vortex Implantable Access Port
n=50 Participants
Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
|
|---|---|---|
|
Termination of Use of the Indwelling Port at 12 Months After Port Insertion
|
31 participants
|
31 participants
|
Adverse Events
Standard Access Port
Vortex Implantable Access Port
Serious adverse events
| Measure |
Standard Access Port
n=49 participants at risk
Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
|
Vortex Implantable Access Port
n=50 participants at risk
Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
|
|---|---|---|
|
Vascular disorders
Vascular - Other
|
8.2%
4/49 • Number of events 4
|
4.0%
2/50 • Number of events 2
|
|
Infections and infestations
Infection with unknown ANC: Blood
|
4.1%
2/49 • Number of events 2
|
4.0%
2/50 • Number of events 3
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place