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

Not Applicable

Completed

• Conditions: Focus of Study
• Interventions: Device: PICC or subcutaneous venous port

• Registration Number: NCT01971021
• Lead Sponsor: Linkoeping University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-09-24
• Study First Submitted QC: 2013-10-22
• Study First Posted: 2013-10-28
• Status Verified: 2018-01
• Primary Completion: 2018-01-29
• Last Update Submitted: 2018-01-29
• Last Update Posted: 2018-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PORT	PICC or subcutaneous venous port	Subcutaneous venous port insertion
PICC-line	PICC or subcutaneous venous port	PICC line insertion.

Primary Outcome Measures

Name	Time	Method
The occurence of catheter related venous thrombosis	Upon clinical suspiscion during the one the patient i enrolled in the study	regular follow-ups at month 1, 3, 6 and 12.

Trial Locations

Locations (1)

Dept of Oncology; 🇸🇪 Jönköping, Sweden