Port-a-cath and Hickman line devices for chemotherapy delivery

ISRCTN	ISRCTN79422566
DOI	https://doi.org/10.1186/ISRCTN79422566
Secondary identifying numbers	Protocol/Serial No: MI93

Submission date: 25/01/2013
Registration date: 06/03/2013
Last edited: 01/03/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-study-comparing-two-different-types-central-lines-people-due-start-course-chemotherapy

Contact information

Prof Jonathan Moss
Scientific

Dept of Radiology
Gartnavel General Hospital
1053 Great Western Road
Glasgow
G12 0DY
United Kingdom

Email	jon.moss@ggc.scot.nhs.uk

Study information

Study design	Multi-centre open randomised study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please contact Judith Dixon [judith.dixon@glasgow.ac.uk] to request a patient information sheet
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
Study objectives	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.
Ethics approval(s)	West of Scotland REC 1, 05/04/2011, ref: 11/AL/0083
Health condition(s) or problem(s) studied	Cancer, Chemotherapy, device study
Intervention	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.
Intervention type	Device
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)
Primary outcome measure	Cost effectiveness of Ports
Secondary outcome measures	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.
Overall study start date	01/08/2011
Completion date	01/07/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	100
Key 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
Key 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
Date of first enrolment	09/08/2011
Date of final enrolment	01/07/2013

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centres

Gartnavel General Hospital

Dept of Radiology
1053 Great Western Road
Glasgow
G12 0DY
United Kingdom

Inverclyde Royal Hospital

Larkfield Road
Greenock
PA16 0XN
United Kingdom

Sponsor information

NHS Greater Glasgow and Clyde (UK)
Hospital/treatment centre

c/o Dr Nathaniel Brittain
Academic Research Co-ordinator
Research and Development
Western Infirmary
Dumbarton Road
Glasgow
G11 6NT
Scotland
United Kingdom

Email	Nathaniel.Brittain@ggc.scot.nhs.uk
Website	http://www.nhsggc.org.uk
"ROR"	https://ror.org/05kdz4d87

Funders

Funder type

Government

Chief Scientist Office (UK) - Scottish Government (CZG/2/512)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results:	26/04/2016		Yes	No

Editorial Notes

01/03/2019: Internal review.
04/08/2016: Verified study information with principal investigator. Added publication. Added data sharing plan. Added additional trial participant centre. Changed recruitment start date from 01/08/2011 to 09/08/2011. Changed recruitment end date from 31/07/2012 to 01/07/2013