Contact information
Type
Scientific
Primary contact
Dr Andy Lowe
ORCID ID
Contact details
Department of Clinical Radiology
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
+44 (0)1274 364492
andylowe@doctors.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0050149623
Study information
Scientific title
Computed tomography (CT)-guided intervention with and without fluoroscopic control: what are the benefits for the patient and the doctor?
Acronym
Study hypothesis
Does the introduction of fluoroscopy in computed tomography (CT)-guided intervention decrease procedure time and dose exposure and does it make the procedure technically easier and improve outcome?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled 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 contact details to request a participant information sheet
Condition
Computed tomography-guided interventions
Intervention
All patients attending for CT-guided interventions (biopsies and drainages) are invited to take part. Patients randomised to have procedure in conventional manner with CT guidance (controls) or with additional fluoroscopy. Time taken to have procedure, effective dose to patient, operator and assistant, patient comfort and acceptability, number of passes/complications and degree of technical success measured.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
1. Dose product to patient
2. Effective dose to patient
3. Effective dose to doctor and nurse/assistant
4. Hand dose to doctor
5. Screening time
All measured using electronic dose meters
6. Comfort and acceptability Questionnaire
7. BIOPSY - Number of passes, complications and diagnostic specimens
8. DRAINAGES - Number of passes, Complications and Technical success
Secondary outcome measures
No secondary outcome measures
Overall trial start date
28/05/2004
Overall trial end date
28/11/2004
Reason abandoned
Eligibility
Participant inclusion criteria
All adult in-patients and out-patients attending for CT guided biopsies and drainages
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Acute emergency cases
2. Inability to give informed consent
3. Unconscious patients
Recruitment start date
28/05/2004
Recruitment end date
28/11/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bradford Royal Infirmary
Bradford
BD9 6RJ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Bradford Teaching Hospitals NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Own account funding (UK)
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
Results - basic reporting
Publication summary