Hickman catheter and implantable port devices for the delivery of chemotherapy: a phase II randomised controlled trial and economic evaluation.
BACKGROUND
In the United Kingdom, totally implantable venous access systems (TIVAS) are not routinely used. Compared with Hickman catheters, these devices are more expensive and complex to insert. However, it is unclear whether the higher costs may be offset by perceived greater health benefits. This pilot trial aimed to generate relevant data to inform the design of a larger definitive randomised controlled trial.


METHODS
This was a phase II prospective, randomised, open trial from two UK oncology centres. The primary end point was overall complication rate. Secondary end points included individual complication rates, time to first complication and quality of life. Analysis was by intention to treat. An economic evaluation was also carried out.


RESULTS
A total of 100 patients were randomised in a 3 : 1 ratio to receive a Hickman or a TIVAS. Overall, 54% of patients in the Hickman arm suffered one or more complications compared with 38% in the TIVAS arm (one-sided P=0.068). In the Hickman arm, 28% of the devices were removed prematurely due to a complication compared with 4% in the TIVAS arm. Quality of life based on the device-specific questionnaire was greater in the TIVAS arm for 13 of the 16 questions. The economic evaluation showed that Hickman arm was associated with greater mean cost per patient £1803 (95% CI 462, 3215), but similar quality-adjusted life years -0.01 (95% CI -0.15, 0.15) than the TIVAS arm. However, there is much uncertainty associated with the results.


CONCLUSIONS
Compared with Hickman catheters, TIVAS may be the cost-effective option. A larger multicentre trial is needed to confirm these preliminary findings.
Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, 1 Lilybank Gardens, Glasgow G12 8RZ, UK.
Olivia
O
Wu
Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, 1 Lilybank Gardens, Glasgow G12 8RZ, UK.
Kathleen
K
Boyd
Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, 1053 Great Western Road, Glasgow G12 0YN, UK.
Jim
J
Paul
Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, 1053 Great Western Road, Glasgow G12 0YN, UK.
Elaine
E
McCartney
Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, 1 Lilybank Gardens, Glasgow G12 8RZ, UK.|Interventional Radiology Unit, Gartnavel General Hospital, 1053 Great Western Road, Glasgow G12 0YN, UK.
Moira
M
Ritchie
Beatson West of Scotland Cancer Centre, 1053 Great Western Road, Glasgow G12 0YN, UK.
D
D
Mellon
School of Health Nursing and Midwifery, University of West of Scotland, Caird Building, Hamilton ML3 0JB, UK.
Linda
L
Kelly
Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, 1053 Great Western Road, Glasgow G12 0YN, UK.
Judith
J
Dixon-Hughes
Interventional Radiology Unit, Gartnavel General Hospital, 1053 Great Western Road, Glasgow G12 0YN, UK.
Jon
J
Moss
D002405:Catheterization, Central Venous / Q000191:economics / Q000379:methods*; D003362:Cost-Benefit Analysis; D016503:Drug Delivery Systems / Q000191:economics / Q000379:methods*; D004358:Drug Therapy / Q000191:economics / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies