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
Protocol serial number	N0436165595
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders	Leeds Teaching Hospitals NHS Trust - NHS R&D Support Funding, CIRSE (Cardiovascular and Interventional Radiological Society of Europe)

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

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/06/2007
Reason abandoned (if study stopped)	Participant recruitment issue

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	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

Radiology/Ultrasound Department

Leeds
LS9 7TF
United Kingdom

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