Radio Frequency Ablation (RFA) of Renal Cell Carcinoma Prior to Nephron Sparing Surgery: A pilot study to assess completeness of ablation, accuracy of post-ablation imaging and the contribution of RFA to technical ease of the surgery

ISRCTN	ISRCTN33713464
DOI	https://doi.org/10.1186/ISRCTN33713464
Secondary identifying numbers	N0436165595

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 16/10/2012

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Cancer

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 Tze Wah
Scientific

Radiology/Ultrasound Department
Lincoln Wing
Beckett Street
Leeds
LS9 7TF
United Kingdom

Phone	+44 0113 206 4330
Email	Tze.wah@leedsth.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	The principal aims are to assess the completeness of the RF ablation and the accuracy of radiology imaging (with contrast enhanced ultrasound, CT and MRI) in assessing the tumour for residual RCC after treatment by correlation with pathological examination of the explanted specimen.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer: Renal
Intervention	1. 5 patients in the control group (surgery only) 2. 5 patients will undergo percutaneous RFA of their RCC 14 days before laparoscopic or open partial nephrectomy Please note, the trial was stopped due to a lack of recruitment.
Intervention type	Other
Primary outcome measure	The efficacy of RFA using the current technique in achieving complete tumour ablation will be assessed. Greater than 90% tumour destruction is desirable with the current technique. For contrast enhanced US, CT and MRI the positive predictive value in assessing tumour destruction will be evaluated by correlation with the histological analysis of the explanted kidneys. Accuracy of greater than 80% for each test would be desirable and all modalities should be comparable in predicting tumour destruction
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/06/2005
Completion date	01/06/2007
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	10
Key inclusion criteria	10 candidates for partial nephrectomy ie with solitary RCC (less than 4 cm).
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/06/2005
Date of final enrolment	01/06/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Radiology/Ultrasound Department

Leeds
LS9 7TF
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Research organisation

Leeds Teaching Hospitals NHS Trust - NHS R&D Support Funding

No information available

CIRSE (Cardiovascular and Interventional Radiological Society of Europe)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan