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ISRCTN
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ISRCTN23480116
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ClinicalTrials.gov identifier
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Public title
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Computed tomography (CT)-guided intervention with and without fluoroscopic control: what are the benefits for the patient and the doctor?
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0050149623
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Study hypothesis
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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?
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Computed tomography-guided interventions
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Participants - inclusion criteria
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All adult in-patients and out-patients attending for CT guided biopsies and drainages
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Participants - exclusion criteria
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1. Acute emergency cases
2. Inability to give informed consent
3. Unconscious patients
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Anticipated start date
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28/05/2004
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Anticipated end date
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28/11/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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50
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Interventions
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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.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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1. Bradford Teaching Hospitals NHS Foundation Trust (UK)
2. Own account funding (UK)
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Trial website
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Publications
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Contact name
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Dr
Andy
Lowe
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Address
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Department of Clinical Radiology
Bradford Royal Infirmary
Duckworth Lane
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City/town
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Bradford
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Zip/Postcode
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BD9 6RJ
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Country
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United Kingdom
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Tel
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+44 (0)1274 364492
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Fax
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+44 (0)1274 364304
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Email
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andylowe@doctors.org.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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07/04/2010
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Date ISRCTN assigned
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30/09/2005
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