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

November 15, 2024 updated by: European Institute of Oncology

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

852

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Aviano, Italy, 33081
        • CRO (Centro di Riferimento Oncologico)
        • Contact:
      • Florence, Italy, 50134
      • Milan, Italy, 20141
        • European Institute of Oncology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PICC-port arm
Implantation of a PICC-port device
Device: PICC-port
Implantation of a PICC-port device by a dedicated PICC team member following predefined evidence-based international guidelines and protocols
Active Comparator: Chest-port arm
Implantation of a Chest-port device
Device: Chest-port
Implantation of a Chest-port device by expert physicians or certified expert nurses, following predefined evidence-based international guidelines and protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of device failures
Time Frame: 6 months
Number of unscheduled removal of the device due to complications
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events associated to device
Time Frame: 6 months
Number of adverse events associated with the implantation and use of the device that do not necessitate its removal
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Investigators

  • Principal Investigator: Roberto Biffi, MD, European Istitute of Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 15, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • L2-113

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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