Patient Reported Outcome After Nephron Sparing Treatment of Small Renal Tumours

Region of Southern Denmark

Status: Active, not recruiting

Conditions: Quality of Life; Renal Cell Carcinoma

Treatments: Procedure: Partial nephrectomy; Procedure: CT-guided cryoablation

Study type: Observational

Funder types: Other

Identifiers

NCT04040530

Nephspare PRO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 187 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Trial design

187 participants in 2 patient groups

Cryoablation

Description:

Consecutive patients diagnosed with biopsy proven renal cell carcinoma at stadium T1a or T1b, from the Region of Southern Denmark or Region Zealand, treated with CT-guided cryoablation at Odense University Hospital in the period from 1/6-2019 to 1/6-2021.

Treatment:

Procedure: CT-guided cryoablation

Partial nephrectomy

Description:

Consecutive patients diagnosed with biopsy proven renal cell carcinoma at stadium T1a or T1b, from the Region of Southern Denmark or Region Zealand, treated with partial nephrectomy at Odense University Hospital or Zealand University Hospital in the period from 1/6-2019 to 1/6-2021.

Treatment:

Procedure: Partial nephrectomy