Patient Reported Outcome After Nephron Sparing Treatment of Small Renal Tumours

  • STATUS
    Recruiting
  • End date
    Jun 7, 2026
  • participants needed
    320
  • sponsor
    Region of Southern Denmark
Updated on 25 January 2021
cancer
carcinoma
kidney tumor
nephrectomy

Summary

The present study is an observational study designed to assess and compare clinical outcome and quality of life after nephron sparing treatment of small renal tumors.

Partial nephrectomy, where the tumor is being be surgically removed, has traditionally been the preferred nephron sparing treatment for small renal cell carcinomas (RCC). Cryoablation was introduced 20 years ago as a treatment option for patients with RCC with a high surgical risk. Previously, this group of patients had no available treatment. Cryoablation is a minimally invasive treatment that uses extreme cold to destroy the cancer. In recent years, indications for cryoablation of RCC has extended. Cryoablation is now offered as a curative treatment, also including patients without severe comorbidity.

Retrospective studies imply that patients with RCC have lower quality of life compared to other cancers and that choice of treatment and remaining healthy renal tissue have a correlation with quality of life. Knowledge about the patient perspective is crucial in relation to delivering the highest quality of care in the healthcare system. Exploring quality of life through patient reported outcome is one way of exploring the patient perspective.

In this prospective study the investigators aim to assess clinical outcome and quality of life after partial nephrectomy and cryoablation. Results are expected to generate evidence-based knowledge essential in treatment decisions for RCC globally.

Description

The overall aim of this prospective study is to assess and compare clinical outcome and health related quality of life after partial nephrectomy and cryoablation of renal tumors at stadium T1 in adult patients. The specific objectives is:

  • To describe treatment characteristics (treatment type, knife time, type of anaesthesia) with i) cryoablation and ii) partial nephrectomy on patients with T1 renal tumors in the Regions of Southern Denmark and Zealand.
  • To describe self-reported health related quality of life in adult patients with T1 renal tumors undergoing i) cryoablation and ii) partial nephrectomy in the Regions of Southern Denmark and Zealand.
  • To compare patient and tumor characteristics (age, sex, BMI, performance status, American Society of Anaesthesiologists' (ASA) classification group, comorbidity, other cancer diagnosis, smoking and alcohol use, tumor location and size, and tumor histology) in patients with T1 renal tumors treated with i) Cryoablation or ii) partial nephrectomy in the Regions of Southern Denmark and Zealand.
  • To compare complications, length of hospital stay, treatment success within follow-up, readmission rate and in-hospital mortality after after i) cryoablation and ii) partial nephrectomy of renal tumors at stadium T1 in adult patients in the Regions of Southern Denmark and Zealand.
  • To compare self reported quality of life after i) cryoablation and ii) partial nephrectomy of renal tumors at stadium T1 in adult patients in the Regions of Southern Denmark and Zealand.
  • To identify potential patient or tumor characteristics reducing quality of life after i) cryoablation and ii) partial nephrectomy of renal tumors at stadium T1 in adult patients in the Regions of Southern Denmark and Zealand.

All eligible patients will be offered inclusion. Patients will be allocated to treatment group based on shared decision making between the patient and the treating urologist and recommendation from a multidisciplinary team conference. This reflecting the clinical practice.

Details
Condition Adenocarcinoma, Malignant neoplasm of kidney, Renal Cell Carcinoma, Quality of life, Kidney Cancer, Malignant Adenoma, Renal Cell Cancer, Renal Cancer, clear cell renal cell carcinoma, quality-of-life
Treatment Partial nephrectomy, CT-guided cryoablation
Clinical Study IdentifierNCT04040530
SponsorRegion of Southern Denmark
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Renal Cell Cancer or Kidney Cancer or Malignant neoplasm of kidney or Malignant Adenoma or Renal Cancer or Quality of life or Adenocarcinoma or Renal ...?
Do you have any of these conditions: Malignant Adenoma or Kidney Cancer or Adenocarcinoma or Quality of life or Renal Cancer or quality-of-life or clear cell renal cell carcinoma or Renal...?
Patients undergoing CT-guided cryoablation of histologically verified primary renal cancer at stage T1
Patients undergoing partial nephrectomy of histologically verified primary renal cancer at stage T1
Patients who understand and read Danish

Exclusion Criteria

Patients diagnosed with dementia
Patients with tumours > 7 cm
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