Patient Reported Outcome After Nephron Sparing Treatment of Small Renal Tumours

Quality of Life Clinical Trial

Official title:

Patient Reported Outcome After Nephron Sparing Treatment of Small Renal Tumours

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04040530
• Other study ID #: Nephspare PRO
• Status: Active, not recruiting
• Start date: June 7, 2019
• Est. completion date: February 7, 2026

Study information

• Verified date: November 2023
• Source: Region of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 187
• Est. completion date: February 7, 2026
• Est. primary completion date: February 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Quality of Life
• Renal Cell Carcinoma

Intervention

Procedure:
• CT-guided cryoablation
Percutaneous computed tomography guided cryoablation with the patient in sedation or general anaesthesia.
• Partial nephrectomy
Surgical removal of the renal cancer, leaving the healthy renal tissue. Surgery is either done laparoscopically, robot-assisted laparoscopically or as an open surgery. The patient is under general anaesthesia.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense C
Denmark	Zealand University Hospital	Roskilde

Sponsors (3)

Lead Sponsor	Collaborator
Region of Southern Denmark	Region Zealand, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in health-related Quality of life measured by the validated Danish version of The European Organisation for Research and Treatment of Cancer - Core Quality of Life Questionnaire (EORTC QLQ C-30)	EORTC QLQ C- 30 will be used for quality of life measurement. A scale range 0-100, a higher score indicating better quality of life within five functional scales ( physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status scale and the following six single item symptom measures; dyspnea, insomnia, appetite loss, constipation, diarrhea, and functional difficulties.	Change from baseline at 14 days and 3 months postoperatively.
Primary	Change from baseline in health-related Quality of life (HRQoL) to 3 months after treatment measured by the validated Danish version of SF-12v2.	HRQoL will be assessed by the Short Form 12 version 2.0 (SF-12v2) Health Survey scores.	3 months
Primary	Self evaluation of rehabilitation and experience of course of treatment measured by a locally validated questionnaire.	Patients' self evaluation of rehabilitation and course of treatment will be assessed by the locally validated rehabilitation questionnaire for renal cancer (RQRC). The questionnaire consists of seven items. Responses will be reported in percentages.	3 months
Primary	Number of participants with treatment related complications within the first 30 days after treatment.	Graded and classified according to the Clavien-Dindo classification.	30 days
Primary	Number of participants with treatment related complications between 30 and 90 days after treatment.	Graded and classified according to the Clavien-Dindo classification.	From 30 to 90 days postoperatively
Primary	Number of participants who are readmitted to the hospital after discharge from treatment.	Readmission to the hospital after discharge	Within the first 30 days postoperatively
Primary	Treatment success	The degree of incomplete ablation after cryoablation, visualized on CT, in comparison with the degree of positive surgical margin after partial nephrectomy, from histopathology.	3 months
Secondary	Length of hospital stay after nephron sparing treatment	Absolute number of days the patient is hospitalized after treatment.	up to 90 days
Secondary	Rate of in-hospital mortality	Mortality under hospitalization after initial treatment	up to 90 days
Secondary	Rate of cancer related mortality	Cancer related mortality calculated from the date of treatment, to the date of death related to renal cell carcinoma or censored at the date at last follow-up.	Minimum of 3 months follow-up and up to 5 years.
Secondary	Change from baseline in health-related Quality of life measured by the validated Danish version of EORTC QLQ C-30.	The European Organisation for Research and Treatment of Cancer - Core Quality of Life Questionnaire (EORTC QLQ C-30) will be used for quality of life measurement. A scale range 0-100, a higher score indicating better quality of life within five functional scales ( physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status scale and the following six single item symptom measures; dyspnea, insomnia, appetite loss, constipation, diarrhea, and functional difficulties.	Change from baseline at 1-5 years postoperatively.
Secondary	Change from baseline in health-related Quality of life (HRQoL) measured by the validated Danish version of SF-12v2.	HRQoL will be assessed by the Short Form 12 version 2.0 (SF-12v2) Health Survey scores.	Change from baseline at 1-5 years postoperatively.