Plain English Summary
Background and study aims
This study aims to compare two kinds of catheters (thin tubes inserted into the body for treatment or surgery): a central venous catheter (CVC) and peripherally inserted central venous catheter (PICC) which is inserted in a vein in the arm instead of a vein in the neck or chest.
Who can participate?
Both male and female patients, who are over 18 years of age, in need of a central venous catheter, who have received information on the study and have given the consent for this study.
What does the study involve?
In-patients and out-patients who are referred to the department for gastrointestinal cancer treatment in Sahlgrenska University Hospital (Sweden).
What are the possible benefits and risks of participating?
There are no known risks. The treatment with these catheters is well documented and well known.
Where is the study run from?
Sahlgrenska University Hospital, Gothenburg, Sweden
When is the study starting and how long is it expected to run for?
The study takes place between January 2013 and December 2015.
Who is funding the study?
Scholarships
Who is the main contact?
Dr Cecilia Engström
cecilia.engstrom@surgery.gu.se
Trial website
Contact information
Type
Scientific
Primary contact
Dr Cecilia Engström
ORCID ID
Contact details
Sahlgrensk University Hostpital/SS
Goteborg
41345
Sweden
cecilia.engstrom@surgery.gu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Randomised clinical trial on venous access comparing central venous catheter and peripher inserted central venous catheter
Acronym
CVC, PICC
Study hypothesis
PICC line use is more safe, with less side-effects and adverse events and perhaps also less expensive and easier to use both for patients and medical personal.
Ethics approval
Board of Ethics in Goteborg, 2011-09-11, ref: Dnr 492-11
Study design
Randomised clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Upper GI disease
Intervention
Patients are enrolled as indoor and outdoor patients and randomised in a way approved before and after patients consent. The specific catheter is inserted by either a specialised nurse or doctor.
Arm 1: CVC treatment
Arm 2: PICC line
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Catheter treatment period: measured in 2014/15 approximately
Secondary outcome measures
Side effects such as thrombosis, thromophlebitis, pneumothorax, hemothorax, deep and surface infections: measured in 2014/15 approximately
Overall trial start date
01/01/2013
Overall trial end date
31/12/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male or Female over 18 yrs in need of a central line
2. Patient has received information of the study and consent is given
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Approximately 250 patients
Participant exclusion criteria
Patient who has no need of central venous access
Recruitment start date
01/01/2013
Recruitment end date
31/12/2015
Locations
Countries of recruitment
Sweden
Trial participating centre
Sahlgrensk University Hostpital/SS
Goteborg
41345
Sweden
Sponsor information
Organisation
Sahlgrenska University Hospital (Sweden)
Sponsor details
Sahlgrenska University Hospital/SS
Goteborg
41345
Sweden
cecilia.engstrom@surgery.gu.se
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Sahlgrenska University Hospital (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list