Is partial removal of the kidney better than removing the whole kidney for patients with intermediate-size kidney tumours?
| ISRCTN | ISRCTN11293415 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11293415 |
| IRAS number | 318662 |
| Secondary identifying numbers | CPMS 54664, IRAS 318662 |
- Submission date
- 16/01/2023
- Registration date
- 19/01/2023
- Last edited
- 23/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-two-different-types-of-surgery-for-kidney-cancer-partial
Background and study aims
PARTIAL is a research study looking at two different types of surgery for kidney cancer. Every year, over 13,000 people in the UK have a tumour on their kidney: some of these are kidney cancer, and others turn out not to be cancer. Often, these tumours are identified when they are at the early stages of growth (up to 7cm), and if there is no spread to other parts of the body the two main types of surgery that can be done are the removal of the whole kidney if there is a normal kidney on the other side (radical nephrectomy) and partial removal of the kidney where only part of the kidney (where the tumour is) is removed (partial nephrectomy). Each of these types of surgery has potential benefits and risks, but there is no good evidence for doctors and surgeons working in the NHS about which operation is better. When surgeons remove part of the kidney, there is a higher chance of bleeding, but in the longer term, the person’s kidney function may be better. It is also unclear which type of surgery is the best option for patients. The PARTIAL study will compare these two different types of surgery to answer the question of whether a partial removal of the kidney is better than removing the whole kidney for a group of more complex kidney tumours suitable for either approach.
Who can participate?
Adult patients in the UK with suspected or confirmed stage T1 renal cell carcinoma (a type of kidney cancer), who are suitable to have either operation by keyhole surgery
What does the study involve?
Adults who consent to participate in PARTIAL will be randomly allocated to one of the two types of surgery mentioned above. We will keep in touch with participants for 24 months to collect information on several things, including how well the kidney(s) are working (through regular blood tests), any complications of surgery and quality of life.
What are the possible benefits and risks of participating?
Both types of surgery are already being used in the NHS to treat patients who need kidney surgery. There are risks associated with all surgical procedures but there should be no additional risk in taking part in the study. Participants may not benefit personally from taking part but, by taking part, will help inform the treatment of future patients who need to have kidney surgery. The results of the PARTIAL study will help doctors, surgeons, patients and health services decision-makers understand whether it is better to remove the whole kidney or part of the kidney.
Where is the study run from?
The Newcastle upon Tyne Hospitals NHS Foundation Trust (UK) and the University of Aberdeen (UK)
When is the study starting and how long is it expected to run for?
June 2022 to June 2027
Who is funding the study?
National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) (UK); Grant Codes: NIHR133561
Who is the main contact?
Diana Johnson, partial@abdn.ac.uk
Contact information
Principal Investigator
Freeman Hospital
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
 ORCID ID |
0000-0002-5203-7695 |
|---|---|
| Phone | +44 (0)191 2137597 |
| partial@abdn.ac.uk |
Principal Investigator
Newcastle University
Paul O’Gorman Building
Medical School
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom
| ORCID ID |
0000-0003-1952-7462 |
|---|---|
| Phone | +44 (0)191 2084300 |
| partial@abdn.ac.uk |
Public
Centre for Healthcare Randomised Trials (CHaRT)
3rd Floor, Health Sciences Building
University of Aberdeen
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
| ORCID ID |
0000-0003-0479-1228 |
|---|---|
| Phone | +44 (0)1224 438144 |
| partial@abdn.ac.uk |
Study information
| Study design | Randomized interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The PARTIAL study: A randomised trial of the clinical and cost-effectiveness of complex PARTIAL versus radical nephrectomy for clinically localised renal cell carcinoma |
| Study acronym | PARTIAL |
| Study hypothesis | Partial nephrectomy for intermediate-sized 4-7cm (T1b) and small <4cm (T1a) endophytic (deep-seated) tumours result in better renal function by at least 10mls/min/1.72m2 compared to radical nephrectomy in patients with a normal contralateral kidney. |
| Ethics approval(s) | Approved 12/12/2022, South West - Central Bristol Research Ethics Committee (Temple Quay House, 2 The Square, Bristol, BS1 6PN, UK; +44 (0)207 1048029; centralbristol.rec@hra.nhs.uk), ref: 22/SW/0171 |
| Condition | Renal cancer |
| Intervention | Potential participants will be identified through hospital urologist clinics and screening in local and regional specialist multi-disciplinary teams. Adults with suspected or confirmed clinically localised kidney cancer on imaging with a normal functioning kidney on the other side and considered suitable for both minimally invasive (keyhole) radical or partial nephrectomy will be considered. Those with suspected kidney cancer are eligible for inclusion due to the low uptake of biopsy amongst patients (as described in section A6-2). Potential participants being considered for open surgery will be excluded from the study as open surgery has significantly more complications than keyhole surgery and is generally reserved for tumours which are outside the inclusion criteria of the study. Eligible participants will be given information about the study. Those who are interested in taking part will discuss the surgical options and the study with a member of the clinical team during a face-to-face or virtual consultation. If the participant decides to give their consent, they will be asked to sign a consent form (electronic or hard copy, as per preference) and complete a baseline questionnaire. Participants can complete this at a consultation or at home. If completed at home, this may be supported by a telephone call from the site (if the participant agrees to this contact) and the consent form and baseline questionnaire, if done as hard copy, will be returned through the post. The local research team will complete a baseline case report form collecting data on age, sex, ethnicity, height, weight, postcode, medical history, smoking status, kidney function (eGFR - measured by a blood test, the standard of care), tumour size and location (measured on imaging, the standard of care) and biopsy results (only if a biopsy is offered as part of the standard of care and if the participant agrees to biopsy). Participants will be randomised to either a partial nephrectomy or a radical nephrectomy. If a participant agrees to a biopsy prior to surgery (as part of the standard of care), the participant will be randomised after the biopsy if the surgeon and patient are still in equipoise about the treatment options. The procedure (radical or partial nephrectomy) is undertaken as per standard care. Blinding is not possible. The local research team will collect information about the surgical procedure, any intraoperative complications and pathology results from medical records (or in real-time, as applicable). Clinical follow-up will coincide with routine follow-up for these participants unless indicated otherwise in the text below. Another follow-up is by questionnaires (post, email, or text). 3 months after surgery, the local research team will collect information from the medical records to complete the Comprehensive Complications Index, recording any complications following surgery. The participant's kidney function (eGFR) will be collected from laboratory records. eGFR is measured by blood tests either post-operatively, at hospital outpatient clinics or in primary care (as applicable). The key measurements of eGFR for PARTIAL are within 1 week of surgery and at 1 month after surgery and 6, 12 and 24 months after randomisation. These blood tests are standard of care post-operatively for those with confirmed renal cancer. Participants who do not have confirmed renal cancer following surgery, these participants will still be followed up in the study but regular kidney function tests may not be part of the standard of care. In such cases, these participants will be invited to attend study-specific follow-ups with the aim of obtaining the kidney function measurement by blood test at the above approximate time points. Participants will be asked to complete questionnaires by post, email or text (as per participant preference) at 1 week and at 1 and 3 months after surgery and 6, 12, 18 and 24 months post-randomisation to collect information (at the relevant time point) on quality of life, quality of recovery, NHS resource use and participant costs, time and travel and acceptability and to report any complications. 24 months after surgery, the local research team will collect information from the medical records including major adverse cardiovascular events, evidence of cancer recurrence (from routine scans), further treatment and any late complications that have occurred since randomisation. Outcomes will then be compared between partial nephrectomy and radical nephrectomy. Participants will give consent for longer-term follow-up - to access the medical information on long-term outcomes including cardiovascular events, survival and kidney function and to access tissue from pathology archives for future studies (based on separate funding and relevant approvals). There is a qualitative sub-study which will identify challenges relating to the design and conduct of the trial, particularly around recruitment. The first component of this involves analysing anonymised screening logs to support recruitment activity. Audi-recording consultations will be implemented at trial sites. Participants will receive information about this in advance of the consultation and will be asked to give verbal agreement for the recording at the start of their consultation. The second component of this will involve interviews with (i) site staff and (ii) participants who consented and declined to participate in PARTIAL. Site staff will be emailed an invitation letter and invited to contact the qualitative research team (by email/telephone) if interested in taking part. Potential participants will be provided with information by the local research teams with a reply slip to complete and return to the qualitative researcher if interested in taking part. Participants who do not return the reply slip will not be contacted further. Participants and site staff interested in taking part will be telephoned by the qualitative researcher and, if they agree to take part, verbal agreement for the interview will be sought at the beginning of the interview. Interviews will be completed by telephone or online (eg. Microsoft TEAMS). Results will be fed back as anonymised summaries to site staff and the project management group to support improvements in recruitment and retention. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Renal function preservation by estimated glomerular filtration rate (eGFR) measured using a blood test and standard procedures at baseline, 1 week and 1 month after surgery and 6, 12 and 24 months after randomisation 2. Surgical complications measured using the Comprehensive Complications Index (CCI) to 3 months after surgery |
| Secondary outcome measures | 1. Health-related quality of life (HRQoL) measured using the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) and the 36-Item Short Form Health Survey (SF-36) acute version (1-week recall) participant questionnaires at baseline, 1 week, 1 month and 3 months after surgery and 3, 6, 12, 18 and 24 months after randomisation 2. Cost-effectiveness (quality-adjusted life-year and costs) measured using case note reviews and participant questionnaires at baseline, surgery, 1 week, 1 month and 3 months after surgery and 3, 6, 12, 18 and 24 months after randomisation 3. Quality of recovery capturing length of stay measured using the 15-item Quality of Recovery-15 (QoR-15) scale participant questionnaire at 1 week, 1 month and 3 months after surgery 4. Rates of positive surgical margin rates and retreatment / surgical revision measured by case note review (pathology report) at surgery and 24 months after randomisation 5. Recurrence-free and overall survival including local recurrence measured by case note review at 24 months after randomisation 6. Cardiovascular events (non-fatal heart attack, non-fatal stroke and cardiovascular death) measured by case note review at 24 months after randomisation 7. Progression to chronic kidney disease stages 3, 4, and 5 (added 04/03/2024: including end-stage renal failure) by estimated glomerular filtration rate (eGFR) measured using a blood test and standard procedures at baseline, 1 week and 1 month after surgery and 6, 12 and 24 months after randomisation 7. Operative conversion to radical nephrectomy measured by case note review at surgery 8. Patient acceptability measured using interviews in embedded mixed methods trial process evaluation and participant questionnaire at 3 months after surgery |
| Overall study start date | 01/06/2022 |
| Overall study end date | 30/06/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 420; UK Sample Size: 420 |
| Participant inclusion criteria | 1. Adults >=18 years 2. Newly diagnosed clinically localised renal cancer (suspected on cross-sectional imaging or histologically confirmed) 3. Local multi-disciplinary review identifying those cases thought to be suitable for both minimally invasive RN or PN; (for minimally invasive we mean laparoscopic or robotic surgery; cases where open surgery is planned are not eligible) 4. Cross-sectional imaging showing a single tumour, stage T1 (up to 7cm), where there is equipoise in the MDT and willingness to recruit into the trial 5. On imaging, evidence of a radiologically normal contralateral kidney 6. Patients that have been fully counselled of all the available treatment options (including non-surgical approaches, where appropriate) 7. Able and willing to give informed consent to participate and to participate in study procedures |
| Participant exclusion criteria | 1. Solitary functioning kidney 2. Metastatic disease 3. Existing Chronic Kidney Disease (> stage 3b; eGFR< 45) 4. Medically unfit for surgery 5. Congenital renal abnormality which includes fusion, assent and malrotation 6. Suspected or confirmed inherited kidney cancer syndrome 7. Current pregnancy or breastfeeding 8. People without capacity |
| Recruitment start date | 01/01/2023 |
| Recruitment end date | 30/06/2025 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
University of Aberdeen
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
Headington
Oxford
OX3 7LE
United Kingdom
Hazel Grove
Stockport
SK2 7JE
United Kingdom
Leicester
LE5 4PW
United Kingdom
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
Coventry
CV2 2DX
United Kingdom
London
SE1 9RT
United Kingdom
Sunderland
SR4 7TP
United Kingdom
Wolverhampton
WV10 0QP
United Kingdom
Edinburgh
Lothian
EH4 2XU
United Kingdom
Exeter
EX2 5DW
United Kingdom
Plymouth
PL6 8DH
United Kingdom
Glasgow
G12 0YN
United Kingdom
Westcliff-on-sea
SS0 0RY
United Kingdom
London
W6 8RF
United Kingdom
Eastbourne
BN21 2UD
United Kingdom
Ethelbert Road
Canterbury
CT1 3NG
United Kingdom
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
London
SW3 6JJ
United Kingdom
Prescot Street
Liverpool
L7 8XP
United Kingdom
Haywards Heath
RH16 4EX
United Kingdom
Arrowe Park Road
Wirral
CH49 5PE
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
Sheffield
S10 2JF
United Kingdom
Wakefield
WF1 4DG
United Kingdom
Aberdeen
AB25 2ZN
United Kingdom
Blackshaw Road
London
SW17 0QT
United Kingdom
Dudley
DY1 2HQ
United Kingdom
Kirkcaldy
KY2 5AH
United Kingdom
Sponsor information
Hospital/treatment centre
Level 1
Regent Point
Regent Farm Road
Gosforth
Newcastle-Upon-Tyne
NE7 7DN
England
United Kingdom
| Phone | +44 (0)1912825959 |
|---|---|
| tnu-tr.sponsormanagement@nhs.net | |
| Website | http://www.newcastle-hospitals.org.uk/ |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
23/04/2025: The recruitment end date was changed from 31/12/2024 to 30/06/2025.
04/03/2024: The following changes were made to the study record:
1. The secondary outcome measures were updated.
2. The study participating centres were updated to remove Royal Stoke University Hospital and add Princess Royal Hospital, Arrowe Park Hospital (site), Royal Free London NHS Foundation Trust, Royal Hallamshire Hospital, Pinderfields Hospital, Aberdeen Royal Infirmary, St George's Hospital, Russells Hall Hospital, and Victoria Hospital.
15/09/2023: The study participating centres East Kent Hospitals University NHS Foundation Trust, University Hospitals of Derby and Burton NHS Foundation Trust, Manchester Royal Royal Infirmary, Leeds Teaching Hospitals NHS Trust, The Royal Marsden Hospital (London), Liverpool University Hospitals NHS Foundation Trust were added.
13/09/2023: The study participating centre Eastbourne District General Hospital was added.
13/07/2023: The study participating centre Charing Cross Hospital was added.
21/03/2023: Cancer Research UK plain English summary link added to plain English summary field.
16/01/2023: Trial's existence confirmed by the NIHR.
