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Port-a-cath and Hickman line devices for chemotherapy delivery
ISRCTN ISRCTN79422566
DOI 10.1186/ISRCTN79422566
ClinicalTrials.gov identifier
EudraCT number
Public title Port-a-cath and Hickman line devices for chemotherapy delivery
Scientific title Port-a-cath and Hickman line devices for chemotherapy delivery: A randomised phase II study and pre-trial economic model development to inform the design of a subsequent randomised phase III controlled trial
Acronym N/A
Serial number at source Protocol/Serial No: MI93
Study hypothesis The study hypothesis is that Ports are cost effective for the delivery of chemotherapy and that it is not appropriate to deny these devices to patients on grounds of purchasing costs alone. Although Ports are a little more difficult to insert and more expensive than Hickman lines, they carry potential advantages such as reduced infection and re-intervention rates, reduced maintenance and superior patient acceptability.
Lay summary http://www.cancerresearchuk.org/cancer-help/trials/a-study-comparing-two-different-types-central-lines-people-due-start-course-chemotherapy
Ethics approval West of Scotland REC 1, 5th April 2011, ethics reference number: 11/AL/0083
Study design Multi-centre open randomised study
Countries of recruitment United Kingdom
Disease/condition/study domain Cancer, Chemotherapy, device study
Participants - inclusion criteria 1. Oncology patients with solid tumours who are scheduled for access line insertion
2. Patients must be willing and clinically able to receive either a Hickman line or a Port-a-cath
3. Patient must provide informed consent
4. Age ≥18 years, male and female
5. Able to comply with study protocol
Participants - exclusion criteria 1. Any evidence of any medical or psychiatric disorders that would be a contra indication to study participation
2. Life expectancy < 3 months
Anticipated start date 01/08/2011
Anticipated end date 31/07/2012
Status of trial Completed
Patient information material Not available in web format, please contact Judith Dixon [judith.dixon@glasgow.ac.uk] to request a patient information sheet
Target number of participants 100
Interventions Patients will be randomised in a 3:1 ratio to receive either a Hickman line (n=75) or a Port-a-cath (n=25).

Patients participating in the study will be asked to complete quality of life questionnaires (EQ-5D and device-specific) at baseline and subsequently monthly (sent out to the patients at home) during the insertion period; a further questionnaire will be completed at the time of planned line removal.

Patients will be seen as per standard of care for their treatment. Complication forms will be completed on a monthly basis by CTU Glasgow staff.
Primary outcome measure(s) Cost effectiveness of Ports
Secondary outcome measure(s) Complication data including line infection (with and without antibiotics), tract infection, (with/without antibiotics), occlusion, migration, loss of line, central vein thrombosis, exit site haematoma, and skin breakdown will be recorded by clinical staff, on complication forms in case notes, as events occur and data collected by the clinical trial coordinator. Reinterventions including line replacement, thrombolysis, stripping and manipulations will be recorded by clinical staff, on complication forms in case notes, as events occur and data collected by the clinical trial coordinator.
Sources of funding Chief Scientist Office (UK) - Scottish Government (CZG/2/512)
Trial website
Publications
Contact name Prof  Jonathan  Moss
  Address Dept of Radiology
Gartnavel General Hospital
1053 Great Western Road
  City/town Glasgow
  Zip/Postcode G12 0DY
  Country United Kingdom
  Email jon.moss@ggc.scot.nhs.uk
Sponsor NHS Greater Glasgow and Clyde (UK)
  Address c/o Dr Nathaniel Brittain
Academic Research Co-ordinator
Research and Development
Western Infirmary
Dumbarton Road
  City/town Glasgow
  Zip/Postcode G11 6NT
  Country United Kingdom
  Email Nathaniel.Brittain@ggc.scot.nhs.uk
  Sponsor website: http://www.nhsggc.org.uk
Date applied 25/01/2013
Last edited 06/03/2013
Date ISRCTN assigned 06/03/2013
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