Central venous access devices are extensively used in oncology patients. The current standard is represented by devices inserted by direct ultrasound guided cannulation of deep veins of supra/infraclavicular area with a reservoir placed in a subcutaneous pocket of the upper chest wall ("chest-ports"). More recently, PICC (Peripherally Inserted Central Catheters)-ports have been proposed as an alternative to chest-ports. Aim of this study is to demonstrate the non-inferiority of PICC ports compared to thoracic ports in terms of efficacy and safety.
Central venous access devices are extensively used in oncology patients who need safe deliverance of chemotherapeutic agents and drugs, transfusion of blood and blood products, and performance of laboratory tests, in solid as well as hematologic malignancies. These devices are mostly inserted by direct ultrasound guided cannulation of deep veins of supra/infraclavicular area and the reservoir is placed in a subcutaneous pocket of the upper chest wall ("chest-ports"). More recently, PICC (Peripherally Inserted Central Catheters)-ports have been proposed as a safe and effective alternative to chest-ports, claiming lower invasiveness, easier insertion and better patients' compliance. In PICC-ports a small reservoir is placed in a subcutaneous pocket located in the mid-third of the upper arm. Since these feelings are currently based only on limited retrospective studies, aim of this randomized multicenter trial is to demonstrate the non-inferiority of PICC ports (experimental arm) compared to thoracic ports (control arm, as the current reference standard) in terms of efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
852
Implantation of a PICC-port device by a dedicated PICC team member following predefined evidence-based international guidelines and protocols
Implantation of a Chest-port device by expert physicians or certified expert nurses, following predefined evidence-based international guidelines and protocols
CRO (Centro di Riferimento Oncologico)
Aviano, Italy
Ospedale Careggi
Florence, Italy
European Institute of Oncology
Milan, Italy
Incidence of device failures
Number of unscheduled removal of the device due to complications
Time frame: 6 months
Incidence of adverse events associated to device
Number of adverse events associated with the implantation and use of the device that do not necessitate its removal
Time frame: 6 months
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