A Phase 2 interventional study of vascular access device placement in Unspecified Adult Solid Tumor, Protocol Specific and Vascular Access Device Complications, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-09.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Supportive care
RATIONALE: Giving chemotherapy drugs through an implanted port reduces the need for multiple needle sticks. It is not yet known whether one type of port is more effective than another in reducing infections and other side effects associated with long-term port use.
PURPOSE: This randomized clinical trial is comparing two types of ports in patients with cancer receiving intravenous chemotherapy.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are randomized to 1 of 2 intervention arms.
All episodes of access to the port are documented for 12 months after port insertion. Information including the reason for port access and difficulty in access is collected. Complications, such as occlusion and infection, implant duration, and incidence of port-related interventions are assessed at 6 and 12 months after port insertion.
Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of malignancy requiring intravenous chemotherapy for ≥ 6 months
PATIENT CHARACTERISTICS:
No active skin condition implicating an elevated risk of local or systemic infectious or non-infectious complications, including any of the following:
No known active infection requiring antibiotic therapy at the time of port implantation
No concurrent illness requiring chronic anticoagulation
PRIOR CONCURRENT THERAPY:
Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
Procedure: vascular access device placement
Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
Procedure: vascular access device placement
Port Failure Within 12 Months of Port Insertion
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.
Time frame: Up to 12 months from port insertion
Death From All Causes
Number of patients that died during treatment due to any cause.
Time frame: Up to 12 months after port insertion
Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion
We report the number of patients that terminated use of port due to any reason other than infection or occlusion within 12 months.
Time frame: Up to 12 months after port insertion
Termination of Use of the Indwelling Port at 12 Months After Port Insertion
The number of patients that discontinued use of inserted port for any reason at the 12 month timepoint.
Time frame: Up to 12 months after port insertion
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.
| Milestone | Standard Access Port | Vortex Implantable Access Port |
|---|---|---|
| Started | 50 | 50 |
| Completed | 49 | 50 |
| Not completed | 1 | 0 |
| Withdrew: Unable to place port due to occlusion | 1 | 0 |
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.
| percentage of patients | Standard Access Port | Vortex Implantable Access Port |
|---|---|---|
| Port Failure Within 12 Months of Port Insertion | 16.1 (3.2 to 29.0) | 13.8 (1.2 to 26.4) |
Number of patients that died during treatment due to any cause.
| participants | Standard Access Port | Vortex Implantable Access Port |
|---|---|---|
| Death From All Causes | 9 | 6 |
We report the number of patients that terminated use of port due to any reason other than infection or occlusion within 12 months.
| participants | Standard Access Port | Vortex Implantable Access Port |
|---|---|---|
| Death | 9 | 6 |
| End of Chemotherapy | 7 | 6 |
| Skin Erosion | 1 | 0 |
| Unhealed Incision | 1 | 0 |
| Thrombosis | 0 | 1 |
| Patient Moved/Transferred Care | 4 | 7 |
| Patient Request | 1 | 0 |
| Unknown | 5 | 10 |
The number of patients that discontinued use of inserted port for any reason at the 12 month timepoint.
| participants | Standard Access Port | Vortex Implantable Access Port |
|---|---|---|
| Termination of Use of the Indwelling Port at 12 Months After Port Insertion | 31 | 31 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Access Port | — | 5/49 (10.2%) | 0/49 (0%) |
| Vortex Implantable Access Port | — | 4/50 (8%) | 0/50 (0%) |
| Event | Standard Access Port | Vortex Implantable Access Port |
|---|---|---|
| Vascular - OtherVascular disorders | 4/49 | 2/50 |
| Infection with unknown ANC: BloodInfections and infestations | 2/49 | 2/50 |
All 100 patients accrued to participate in this study were included in the baseline population analysis.
| Age, Continuous(years) | Standard Access Port | Vortex Implantable Access Port | Total |
|---|---|---|---|
| Median | 65 (35 to 93) | 64 (31 to 81) | 65 (31 to 93) |
| Sex: Female, Male(Participants) | Standard Access Port | Vortex Implantable Access Port | Total |
|---|---|---|---|
| Female | 21 | 24 | 45 |
| Male | 29 | 26 | 55 |
| Region of Enrollment(participants) | Standard Access Port | Vortex Implantable Access Port | Total |
|---|---|---|---|
| United States | 50 | 50 | 100 |
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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