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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PICC-port arm | Experimental | Implantation of a PICC-port device |
|
| Chest-port arm | Active Comparator | Implantation of a Chest-port device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICC-port | Device | Implantation of a PICC-port device by a dedicated PICC team member following predefined evidence-based international guidelines and protocols |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of device failures | Number of unscheduled removal of the device due to complications | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Biffi, MD | Contact | +39 02 57489710 | roberto.biffi@ieo.it |
| Name | Affiliation | Role |
|---|---|---|
| Roberto Biffi, MD | European Istitute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRO (Centro di Riferimento Oncologico) | Aviano | 33081 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18971486 | Background | Gallieni M, Pittiruti M, Biffi R. Vascular access in oncology patients. CA Cancer J Clin. 2008 Nov-Dec;58(6):323-46. doi: 10.3322/CA.2008.0015. Epub 2008 Oct 29. | |
| 24841352 | Background | Biffi R, Pozzi S, Bonomo G, Della Vigna P, Monfardini L, Radice D, Rotmensz N, Zampino MG, Fazio N, Orsi F. Cost effectiveness of different central venous approaches for port placement and use in adult oncology patients: evidence from a randomized three-arm trial. Ann Surg Oncol. 2014 Nov;21(12):3725-31. doi: 10.1245/s10434-014-3784-5. Epub 2014 May 20. |
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Prospective, randomized, multicenter, open-label, non-inferiority clinical trial
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| Chest-port | Device | Implantation of a Chest-port device by expert physicians or certified expert nurses, following predefined evidence-based international guidelines and protocols |
|
| Ospedale Careggi | Florence | 50134 | Italy |
|
| European Institute of Oncology | Milan | 20141 | Italy |
|
| 24659216 | Background | Biffi R, Toro A, Pozzi S, Di Carlo I. Totally implantable vascular access devices 30 years after the first procedure. What has changed and what is still unsolved? Support Care Cancer. 2014 Jun;22(6):1705-14. doi: 10.1007/s00520-014-2208-1. |
| 31674857 | Background | Bertoglio S, Cafiero F, Meszaros P, Varaldo E, Blondeaux E, Molinelli C, Minuto M. PICC-PORT totally implantable vascular access device in breast cancer patients undergoing chemotherapy. J Vasc Access. 2020 Jul;21(4):460-466. doi: 10.1177/1129729819884482. Epub 2019 Nov 1. |
| 35034480 | Background | Bertoglio S, Annetta MG, Brescia F, Emoli A, Fabiani F, Fino M, Merlicco D, Musaro A, Orlandi M, Parisella L, Pinelli F, Reina S, Selmi V, Solari N, Tricarico F, Pittiruti M. A multicenter retrospective study on 4480 implanted PICC-ports: A GAVeCeLT project. J Vasc Access. 2022 Jan 17:11297298211067683. doi: 10.1177/11297298211067683. Online ahead of print. |
| 38211609 | Background | Nickel B, Gorski L, Kleidon T, Kyes A, DeVries M, Keogh S, Meyer B, Sarver MJ, Crickman R, Ong J, Clare S, Hagle ME. Infusion Therapy Standards of Practice, 9th Edition. J Infus Nurs. 2024 Jan-Feb 01;47(1S Suppl 1):S1-S285. doi: 10.1097/NAN.0000000000000532. No abstract available. |
| 31308748 | Background | Li G, Zhang Y, Ma H, Zheng J. Arm port vs chest port: a systematic review and meta-analysis. Cancer Manag Res. 2019 Jul 3;11:6099-6112. doi: 10.2147/CMAR.S205988. eCollection 2019. |
| 32104708 | Background | Liu Y, Li LL, Xu L, Feng DD, Cao Y, Mao XY, Zheng J, Jin F, Chen B. Comparison between Arm Port and Chest Port for Optimal Vascular Access Port in Patients with Breast Cancer: A Systematic Review and Meta-Analysis. Biomed Res Int. 2020 Feb 13;2020:9082924. doi: 10.1155/2020/9082924. eCollection 2020. |
| 35533088 | Background | Annetta MG, Bertoglio S, Biffi R, Brescia F, Giarretta I, Greca A, Panocchia N, Passaro G, Perna F, Pinelli F, Pittiruti M, Prisco D, Sanna T, Scoppettuolo G. Management of antithrombotic treatment and bleeding disorders in patients requiring venous access devices: A systematic review and a GAVeCeLT consensus statement. J Vasc Access. 2022 Jul;23(4):660-671. doi: 10.1177/11297298211072407. Epub 2022 May 9. |
| 19179550 | Background | Biffi R, Orsi F, Pozzi S, Pace U, Bonomo G, Monfardini L, Della Vigna P, Rotmensz N, Radice D, Zampino MG, Fazio N, de Braud F, Andreoni B, Goldhirsch A. Best choice of central venous insertion site for the prevention of catheter-related complications in adult patients who need cancer therapy: a randomized trial. Ann Oncol. 2009 May;20(5):935-40. doi: 10.1093/annonc/mdn701. Epub 2009 Jan 29. |