NCT06541301

PICC-ports Versus Chest - Ports for Long Term Chemotherapy Deliverance in Oncology Patients

PICC-ports Versus Chest - Ports for Long Term Chemotherapy Deliverance in Oncology Patients Affected by Solid Tumors. A Prospective, Randomized Multicentric, Non Inferiority, Phase III Trial.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 852 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DEVICE	PICC-port	Implantation of a PICC-port device by a dedicated PICC team member following predefined evidence-based international guidelines and protocols
DEVICE	Chest-port	Implantation of a Chest-port device by expert physicians or certified expert nurses, following predefined evidence-based international guidelines and protocols

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2024-08-07
• Last updated: 2024-11-19

Locations

3 sites across 1 country: Italy