A Prospective Randomized Study of the Vortex® Implantable Access Port Versus the BardPort™ Implantable Port in Cancer Patients Receiving Adjuvant Intravenous Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Port Failure Within 12 Months of Port Insertion
研究概览
简要总结
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.
详细描述
OBJECTIVES:
Primary
- To compare the rate of port failure, defined as the occurrence of port malfunction or port infection within 12 months after port insertion, in patients with cancer requiring long-term adjuvant intravenous chemotherapy undergoing insertion of a newly designed, FDA-approved Vortex® implantable vascular access port vs a conventional vascular access port.
Secondary
- To compare the rate of port malfunction or port infection at 6 and 12 months after port insertion.
- To compare the rate of central vein thrombosis at 6 and 12 months after port insertion.
- To compare the rate of port removal for any reason other than infection or occlusion at 6 and 12 months after port insertion.
- To compare the rate of termination of use of the indwelling port at 6 and 12 months after port insertion.
- To compare the death from all causes.
- To compare the incidence of port-related interventions at 6 and 12 months after port insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of malignancy requiring intravenous chemotherapy for ≥ 6 months
- •Must undergo entire course of chemotherapy at the Mayo Clinic in Jacksonville, unless the outside treating institution agrees to submit the research data sheet to Mayo Clinic
- •Scheduled time frame for regular use of the vascular access port ≥ 3 months after port insertion
- •PATIENT CHARACTERISTICS:
- •Life expectancy ≥ 6 months
- •No active skin condition implicating an elevated risk of local or systemic infectious or non-infectious complications, including any of the following:
- •Current skin infection
- •Cutaneous lymphoma
- •Auto-immune disorders
- •Active vasculitis
- •Connective tissue diseases
- •No known active infection requiring antibiotic therapy at the time of port implantation
- •Patients without an active infection who are on chronic antibiotic suppressive therapy are eligible
- •No concurrent illness requiring chronic anticoagulation
- •Patients who develop other comorbidities requiring chronic anticoagulation during the study period are eligible
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
研究组 & 干预措施
Standard Port
Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
干预措施: vascular access device placement (Procedure)
Vortex Implantable Access Port
Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
干预措施: vascular access device placement (Procedure)
结局指标
主要结局
Port Failure Within 12 Months of Port Insertion
时间窗: Up to 12 months from 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.
次要结局
- Death From All Causes(Up to 12 months after port insertion)
- Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion(Up to 12 months after port insertion)
- Termination of Use of the Indwelling Port at 12 Months After Port Insertion(Up to 12 months after port insertion)