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20/96 Partial vs total nephrectomy for clinically localised renal cell carcinoma

 

Contents

Introduction

The aim of the HTA Programme is to ensure that high quality research information on the effectiveness, costs and broader impact of health technology is produced in the most efficient way for those who use, manage, provide care in or develop policy for the NHS. Topics for research are identified and prioritised to meet the needs of the NHS. Health technology assessment forms a substantial portfolio of work within the National Institute for Health Research and each year about fifty new studies are commissioned to help answer questions of direct importance to the NHS. The studies include both primary research and evidence synthesis.

Research question

Does partial nephrectomy result in better outcomes than total nephrectomy in patients with localised primary renal cell carcinoma?

  1. Intervention: Partial nephrectomy to be defined and justified by applicants. 
  2. Patient group: Patients with localised primary renal cell carcinoma where the multidisciplinary team agrees that the patients could be treated with either partial or radical nephrectomy – applicants to define and justify. People with only one functioning kidney should be excluded. 
    Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field. 
  3. Setting: Secondary care.
  4. Control: Total nephrectomy to be defined and justified by applicants. 
  5. Study design: A randomised controlled trial with an internal pilot phase to test the ability to recruit and randomise. Clear stop/go criteria should be provided to inform progression from pilot to full trial.
  6. Important outcomes: To be defined and justified by applicants that should include a trade-off between potential benefits and harms. For example, post-operative complications such as bleeding and urine leaks versus preservation of kidney function, need for surgical revision, local recurrence, recurrence free survival and overall survival, cardiovascular events and stroke, length-of-stay, quality of life, patient acceptability, and cost-effectiveness.
  7. Minimum duration of follow-up: 2 years.
    Longer-term follow up: If appropriate, researchers should consider obtaining consent from participants to allow potential future follow up through efficient means (such as routine data) as part of a separately funded study.

Rationale

Renal cell carcinoma is a fairly common form of cancer that occurs in almost twice as many men as women. Localised renal cell carcinoma is a tumour that has not spread outside of the kidney. Surgical treatment can include partial nephrectomy, where only a portion of the kidney is removed, or total nephrectomy, which is the removal of the entire affected kidney and possibly also the adrenal gland and lymph nodes.

Total nephrectomy used to be the treatment of choice, however, more recently it seems that partial nephrectomy is being used for small localised renal tumours. This has happened due to a number of retrospective studies suggesting better outcomes with partial nephrectomy, mainly in terms of renal function. However, there have been no successful randomised trials comparing the two methods, and the only randomised trial that was attempted suggested that time to death was reduced with partial nephrectomy, though this closed early and was underpowered. In terms of other outcomes (surgery related mortality, cancer specific survival, and time to recurrence) the two methods seem to be similar.

As the use of partial nephrectomy is becoming more common, it is important to determine the benefits and harms to patients of this approach compared to total nephrectomy and as such the NIHR would like to fund a study to answer this question.

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page.  To select this call, use the filters on the right of the screen or search using the call name and/or number.

Your application must be submitted on-line no later than 1pm on the XX2nd December 2020. Applications will be considered by the HTA Funding Committee at its meeting in January 2021.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

IMPORTANT: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May 2021.

Applications received electronically after 1300 hours on the due date will not be considered.

For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition.

For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared.

Should you have any queries please contact us:

Email: htacommissioning@nihr.ac.uk