Computed tomography (CT)-guided intervention with and without fluoroscopic control: what are the benefits for the patient and the doctor?

ISRCTN	ISRCTN23480116
DOI	https://doi.org/10.1186/ISRCTN23480116
Protocol serial number	N0050149623
Sponsor	Department of Health
Funders	Bradford Teaching Hospitals NHS Foundation Trust (UK), Own account funding (UK)

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 05/07/2016

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Andy Lowe
Scientific

Department of Clinical Radiology
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Phone	+44 (0)1274 364492
Email	andylowe@doctors.org.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Computed tomography (CT)-guided intervention with and without fluoroscopic control: what are the benefits for the patient and the doctor?
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	28/11/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	50
Key inclusion criteria	All adult in-patients and out-patients attending for CT guided biopsies and drainages
Key exclusion criteria	1. Acute emergency cases 2. Inability to give informed consent 3. Unconscious patients
Date of first enrolment	28/05/2004
Date of final enrolment	28/11/2004

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Bradford Royal Infirmary

Bradford
BD9 6RJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

05/07/2016: No publications found, verifying study status with principal investigator.