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

Not Applicable

Not yet recruiting

• Conditions: Solid Tumor
• Interventions: Device: PICC-port; Device: Chest-port

• Registration Number: NCT06541301
• Lead Sponsor: European Institute of Oncology

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-08-02
• Study First Submitted QC: 2024-08-02
• Study First Posted: 2024-08-07
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19
• Study Start: 2024-12
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 852

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PICC-port arm	PICC-port	Implantation of a PICC-port device
Chest-port arm	Chest-port	Implantation of a Chest-port device

Primary Outcome Measures

Name	Time	Method
Incidence of device failures	6 months	Number of unscheduled removal of the device due to complications

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

CRO (Centro di Riferimento Oncologico); 🇮🇹 Aviano, Italy

Ospedale Careggi; 🇮🇹 Florence, Italy

European Institute of Oncology; 🇮🇹 Milan, Italy