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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Focus of Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

open label pragmatic

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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PICC-line

PICC line insertion.

Group Type ACTIVE_COMPARATOR

PICC or subcutaneous venous port

Intervention Type DEVICE

PORT

Subcutaneous venous port insertion

Group Type ACTIVE_COMPARATOR

PICC or subcutaneous venous port

Intervention Type DEVICE

Interventions

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PICC or subcutaneous venous port

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No