Solid Tumor
Conditions
Keywords
Solid Tumor, Chest-ports, Peripherally Inserted Central Catheters-ports
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPICC-port
Implantation of a PICC-port device by a dedicated PICC team member following predefined evidence-based international guidelines and protocols
DEVICEChest-port
Implantation of a Chest-port device by expert physicians or certified expert nurses, following predefined evidence-based international guidelines and protocols
Sponsors
European Institute of Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective, randomized, multicenter, open-label, non-inferiority clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* ≥ 18 Age ≤ 75 yrs * Histologic diagnosis of a solid tumour * Need for intravenous , long term (\> 3 months), intermittent chemotherapy (either adjuvant or palliative) * Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-2
Exclusion criteria
* Active infections * Coagulopathy, defined as platelet count \< 50,000/μL and/or Prothrombin time (PT)/International Normalized Ratio (INR) \> 1.5 * Chronic severe renal failure, stage 3b-4-5 or imminent need for a dialysis fistula * Any conditions contraindicating chemotherapy treatments, as valued by treating oncologist * Life expectancy \< 6 months, as valued by treating oncologist * Inability to give an informed consent and/or history of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of device failures | 6 months | Number of unscheduled removal of the device due to complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events associated to device | 6 months | Number of adverse events associated with the implantation and use of the device that do not necessitate its removal |
Countries
Italy
Contacts
Primary ContactRoberto Biffi, MD
Outcome results
None listed