Contact information
Type
Scientific
Primary contact
Mr Khurshid Ridwan Ghani
ORCID ID
Contact details
Urology Research Department
1st Floor
Ingleby House
St Georges Hospital
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
+44 (0)20 8725 0271
Khurshid.ghani@stgeorges.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0236151199
Study information
Scientific title
Acronym
Study hypothesis
To evaluate the use of 3-dimensional multi-detector row computerised tomography (3D MDCT) in the treatment of renal pelvi-calyceal disease. The primary objective is to determine whether 3D MDCT is a valid and reliable pre-operative planning tool for endourological and percutaneous access to the collecting system of the kidney. The secondary objective is to assess whether pre-operative 'virtual endoscopy' performed using the 3D data, aids endourological removal of the calyceal stone.
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
Not Specified
Patient information sheet
Condition
Surgery: Renal
Intervention
Research investigating the application of 3D imaging in endourolgy is in its infancy. To gain percutaneous access to the kidney and perform subsequent renoscopy in order to remove renal stones for example, the urologist and uroradiologist must have excellent 3D spatial awareness. Currently patients have 2D images taken pre-operatively. Interventionalists use this data to mentally reconstruct a 3D image of the internal calyceal anatomy. Understanding the anatomy is key to a successful intervention. What would be of value is a reliable and valid imaging tool that is able to reconstruct in 3D the calyceal anatomy pre-operatively, and aid endourolgical intervention. Normally patients with complex renal stones requiring surgery have IVU's and CT's taken preoperatively at SGH. We aim to obtain out-patient multi-slice CT scans on patients who fit our inclusion criteria, and who will be undergoing percutaneous intervention in the future. The CT scans will be done as an outpatient investigation at the CT scan department of Princess Grace Hospital (the cost of which will be met by PGH administration). 3D CT will allow reconstruction of the fine ramifications of intracalyceal anatomy. It is our hypothesis that with this data, 3D volume reconstruction will help in pre-operative planning, it will allow us to determine best route of access as well as allowing virtual endoscopy to be done prior to the procedure. It is hoped this will have beneficial outcomes in terms of operative ability and morbidity.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
Reduced time to retrieve target calyceal calculus compared to control.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/2003
Overall trial end date
30/09/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
20
Participant exclusion criteria
1. Patients > 30 stone
2. Pregnant women
3. Patients with severe learning difficulties
4. Patients with acute mental illness
Recruitment start date
01/05/2003
Recruitment end date
30/09/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Urology Research Department
London
SW17 0QT
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
St George's Healthcare NHS Trust (UK) NHS R&D Support Funding
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
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19142644
Publication citations
-
Results
Patel U, Walkden RM, Ghani KR, Anson K, Three-dimensional CT pyelography for planning of percutaneous nephrostolithotomy: accuracy of stone measurement, stone depiction and pelvicalyceal reconstruction., Eur Radiol, 2009, 19, 5, 1280-1288, doi: 10.1007/s00330-008-1261-x.