Vascular Access in Cancer Patients - PICC vs PORT in a Randomized Controlled Trial.

Linköping University (LiU)

Status: Completed

Conditions: Focus of Study

Treatments: Device: PICC or subcutaneous venous port

Study type: Interventional

Funder types: Other

Identifiers

NCT01971021

EPN Linkoping 2013/56-31

Details and patient eligibility

About

As of today there is very limited scientific knowledge in whicj of the two vascular access devices (PICC-line or venous ports) that offers the lowest complicationrates in cancerpatients. The study group wants to clearify this unsolved matter by comparing the two systems. Our primary endpoint is the presens of catheter related venous thrombosis. We are also looking at all catheter related complications and patient satisfaction.

Enrollment: 400 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• cancer treatment with need for central venous access
• Age >18 yrs
• Suspected survival > 4 weeks
• Need of central venous access >4 weeks

Exclusion criteria

• Ongoing uncontrolled systemic infection
• Prescence of significant thrombosis/stenosis in arm or central veins
• Unability to communicate
• Probable upcoming need for dialysis fistula

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups

PICC-line

Active Comparator group

Description:

PICC line insertion.

Treatment:

Device: PICC or subcutaneous venous port

PORT

Active Comparator group

Description:

Subcutaneous venous port insertion

Treatment:

Device: PICC or subcutaneous venous port