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

Phase 2

Completed

• Conditions: Cancer, Chemotherapy, device study; Cancer; Malignant neoplasm, unspecified

• Registration Number: ISRCTN79422566
• Lead Sponsor: HS Greater Glasgow and Clyde (UK)

Brief Summary

2016 results: http://www.ncbi.nlm.nih.gov/pubmed/27092784

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-06
• Study Completion: 2013-07-01
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cost effectiveness of Ports

Secondary Outcome Measures

Name	Time	Method
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.