NCT06541301

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
852

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

November 19, 2024

Status Verified

July 1, 2024

Enrollment Period

1.2 years

First QC Date

August 2, 2024

Last Update Submit

November 15, 2024

Conditions

Solid Tumor

Keywords

Solid TumorChest-portsPeripherally Inserted Central Catheters-ports

Outcome Measures

Primary Outcomes (1)

  • Incidence of device failures

    Number of unscheduled removal of the device due to complications

    6 months

Secondary Outcomes (1)

  • Incidence of adverse events associated to device

    6 months

Study Arms (2)

PICC-port arm

EXPERIMENTAL

Implantation of a PICC-port device

Device: PICC-port

Chest-port arm

ACTIVE COMPARATOR

Implantation of a Chest-port device

Device: Chest-port

Interventions

PICC-portDEVICE

Implantation of a PICC-port device by a dedicated PICC team member following predefined evidence-based international guidelines and protocols

PICC-port arm
Chest-portDEVICE

Implantation of a Chest-port device by expert physicians or certified expert nurses, following predefined evidence-based international guidelines and protocols

Chest-port arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CRO (Centro di Riferimento Oncologico)

Aviano, 33081, Italy

Location

Ospedale Careggi

Florence, 50134, Italy

Location

European Institute of Oncology

Milan, 20141, Italy

Location

Related Publications (10)

  • 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.

    PMID: 18971486BACKGROUND

  • 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.

    PMID: 24841352BACKGROUND

  • 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.

    PMID: 24659216BACKGROUND

  • 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.

    PMID: 31674857BACKGROUND

  • 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.

    PMID: 35034480BACKGROUND

  • 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.

    PMID: 38211609BACKGROUND

  • 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.

    PMID: 31308748BACKGROUND

  • 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.

    PMID: 32104708BACKGROUND

  • 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.

    PMID: 35533088BACKGROUND

  • 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.

    PMID: 19179550BACKGROUND

Study Officials

  • Roberto Biffi, MD

    European Istitute of Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Biffi, MD

CONTACT

+39 02 57489710roberto.biffi@ieo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Prospective, randomized, multicenter, open-label, non-inferiority clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2024

First Posted

August 7, 2024

Study Start

December 1, 2024

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

November 19, 2024

Record last verified: 2024-07

Locations

IT(3)