Clinical trial · Interventional
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.
NCT06541301CI-TRIAL-00082716PICCHESTunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chest-port | Device | — | UNRESOLVED |
| PICC-port | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PICC-port arm
- description
- Implantation of a PICC-port device
- interventionNames
- Device: PICC-port
- type
- ACTIVE_COMPARATOR
- label
- Chest-port arm
- description
- Implantation of a Chest-port device
- interventionNames
- Device: Chest-port
Primary outcomes (1)
- measure
- Incidence of device failures
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDGallieni 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 18971486
- BACKGROUNDBiffi 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 24841352
- BACKGROUNDBiffi 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 24659216
- BACKGROUNDBertoglio 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 31674857
- BACKGROUNDBertoglio 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 35034480
- BACKGROUNDNickel 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 38211609
- 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.