A Randomized, Multicentre, Comparative Phase III Study of Catheter-related Complications of an Iterative PICC Placement vs a Long-term PAC in Patients With Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Compare complication rate for iterative placement (PICC) versus long term placement (PAC).
研究概览
简要总结
Peripherally Inserted Central Catheter (PICC) and port-a-cath (PAC) are the most commonly medical devices used for the administration of chemotherapy.
Placement of these devices via central venous access is sometimes responsible for complications.
The incidence of these complications is correlated with the device holding time.
A strategy of iterative PICC placement could significantly reduce these complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women older than 18 years old;
- •Breast cancer diagnosis histologically proven , for any histological subtypes;
- •4 or 6 indication of neoadjuvant or adjuvant chemotherapy; according to hormonal status and HER2 of the tumors, the patient may be treated concomitantly with hormone therapy and / or trastuzumab; Nota Bene: treatment protocol adopted will imperatively be administered in 3-week cycles.
- •Central venous access indication;
- •Ability to understand and willingness to comply with the study monitoring;
- •Affiliated to the French social security system;
- •Informed Consent dated and signed, indicating that the patient has been informed of all pertinent aspects of the study before inclusion.
排除标准
- •Any contraindication for placement of a central venous catheter ( hemostasis disorders , active infection treated with antibiotics , ...);
- •Patient who can't stop anti -vitamin K treatment ( AVK ) ( a relay by Heparin Low Molecular Weight (LMWH) is possible);
- •History of central access, regardless of the indication;
- •Any active disease other than cancer pathology , requiring repeated administration of intravenous therapy ;
- •Patient deprived of liberty;
- •Not monitoring for social, geographical, psychological or family reason.
研究组 & 干预措施
Iterative PICC placement
New PICC placement at each chemotherapy cycle (removed after treatment administration)
干预措施: Iterative PICC placement (Procedure)
Long term implantable device
Port-a-cath inserted prio first chemotherapy cycle and maintained throughout the study
干预措施: Long term PAC placement (Procedure)
结局指标
主要结局
Compare complication rate for iterative placement (PICC) versus long term placement (PAC).
时间窗: 6 months after randomization
Complication rate will be defined by the proportion of patients with at least one of the following complications from the date of randomization to the end of the study: pneumothorax , hemothorax ,veinous thrombosis, migration or expulsion of the device, fissure or rupture of the catheter, catheter obstruction, extravasation.
次要结局
- Success rate for each strategy(6 months after randomization)
- Description of failure causes for each strategy(6 months after randomization)
- Quality of Life in both arms(At Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1)
- Level of pain for each strategy(At Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1)