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Trial Title:
PICC-ports Versus Chest - Ports for Long Term Chemotherapy Deliverance in Oncology Patients
NCT ID:
NCT06541301
Condition:
Solid Tumor
Conditions: Keywords:
Solid Tumor
Chest-ports
Peripherally Inserted Central Catheters-ports
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Prospective, randomized, multicenter, open-label, non-inferiority clinical trial
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
PICC-port
Description:
Implantation of a PICC-port device by a dedicated PICC team member following predefined
evidence-based international guidelines and protocols
Arm group label:
PICC-port arm
Intervention type:
Device
Intervention name:
Chest-port
Description:
Implantation of a Chest-port device by expert physicians or certified expert nurses,
following predefined evidence-based international guidelines and protocols
Arm group label:
Chest-port arm
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CRO (Centro di Riferimento Oncologico)
Address:
City:
Aviano
Zip:
33081
Country:
Italy
Contact:
Last name:
Fabrizio Brescia
Phone:
347 877 87 16
Email:
fabrizio.brescia@cro.it
Facility:
Name:
Ospedale Careggi
Address:
City:
Florence
Zip:
50134
Country:
Italy
Contact:
Last name:
Fulvio Pinelli
Phone:
349 050 42 97
Email:
fulvio.pinelli@unifi.it
Facility:
Name:
European Institute of Oncology
Address:
City:
Milan
Zip:
20141
Country:
Italy
Contact:
Last name:
Roberto Biffi, MD
Phone:
+39 02 57489710
Email:
roberto.biffi@ieo.it
Facility:
Name:
Ospedale Santo Spirito
Address:
City:
Pescara
Zip:
65122
Country:
Italy
Contact:
Last name:
Antonio Potere
Phone:
333 299 17 51
Email:
antonypower@tiscali.it
Start date:
August 2024
Completion date:
February 2026
Lead sponsor:
Agency:
European Institute of Oncology
Agency class:
Other
Source:
European Institute of Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06541301
