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

European Institute of Oncology

Status: Not yet enrolling

Conditions: Solid Tumor

Treatments: Device: Chest-port; Device: PICC-port

Study type: Interventional

Funder types: Other

Identifiers

NCT06541301

L2-113

Details and patient eligibility

About

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.

Full 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.

Enrollment: 852 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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852 participants in 2 patient groups

PICC-port arm

Experimental group

Description:

Implantation of a PICC-port device

Treatment:

Device: PICC-port

Chest-port arm

Active Comparator group

Description:

Implantation of a Chest-port device

Treatment:

Device: Chest-port