Short summary

Partial nephrectomy (PN) has traditionally been the preferred nephron sparing treatment for small renal cell carcinomas (RCC). Cryoablation (Cryo) is a minimally invasive treatment alternative. 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.  No prospective studies have been performed addressing both clinical outcome and quality of life after nephron sparing treatment for RCC. Furthermore, only a few retrospective studies comparing PN to Cryo have been published. In this prospective study we aim to assess clinical outcome and quality of life after PN and Cryo.  

Rationale

Approximately 900 new RCCs were diagnosed in Denmark in 2015. The incidence of RCC has increased and account for 3-4% of all new cancers in adults. More than 50% of RCCs are being reported as incidental findings. Thus, more tumours are being diagnosed at the clinical T1 stage (< 7cm), localized to the kidney with 80% malignant tumours and about 20-25% potentially aggressive RCC at the time of diagnosis. 

Historically surgical removal of the entire kidney (radical nephrectomy) has been the gold standard for treatment of localised RCC. But since the increase in incidence, regarding tumours in the clinical T1 stage, nephron sparing approaches has become more relevant. With nephron sparing treatment only the area containing the tumour is removed. Within the nephron sparing treatment regimen the aim is to preserve as much kidney function as possible, thus reduce the risk of chronic kidney disease (CKD). CKD increases the risk of kidney failure and cardiovascular disease leading to an increased overall mortality and has also been associated with a decreased quality of life. Nephron sparing treatment is either surgical resection of the kidney (PN) or ablation therapy e.g. cryoablation (Cryo), which shows to be superior compared to other ablation therapies, when it comes to oncological control. With Cryo the tumour is exposed to extreme cold, destroying the cancer. Only a few studies compare Cryo and PN, most of them being retrospective and biased due to selection of patients.

Both Cryo and laparoscopic PN are considered a minimal invasive treatment. Cryo was introduced more than 20 years ago. Initial as a treatment option for the elderly or comorbid patients that could not undergo traditional surgical treatment. Recently, the indication for Cryo has expanded, including younger and non-comorbid patients. PN requires general anaesthesia and hospitalisation. Whereas OUH provides the possibility of performing Cryo in sedation in an outpatient setting. Thus, leading Cryo to be significantly cheaper than traditional surgery, supporting a value-based healthcare agenda and potentially increases the patient satisfactory significantly. 

The patient perspective

During the last decades, there has been a change in paradigm in the Danish healthcare system. The patient has moved from a passive role towards a more active role in managing their own health. Patients expect to participate and they are actively engaged with the healthcare provider, often with expert knowledge. The patients and their relatives are considered a positive resource in the healthcare system. Knowledge about the patient perspective is therefore crucial in relation to delivering the highest quality of care in the healthcare system. Furthermore, including the patient perspective contributes to increased patient satisfaction, improved compliance and increased quality of life. 

Patient reported outcome 

One way of investigating the patient perspective is through patient reported outcome(PRO). PRO provides information about health related quality of life from the patient's perspective. The U.S. Food and Drug Administration define PRO as: "any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else". Leading trade unions and the regions of Denmark has declared a shared goal to incorporate PRO as a key element in quality development in the national healthcare system. Information about quality of life and self-reported health status is often used in health science to gain information about the patient perspective.

Quality of life

Being diagnosed and treated for cancer has an impact on the patient's life and can result in both physical and psychological consequences. The term quality of life covers both the physical and psychological well-being of the patient. Studies show that more than 70% of patients with localised RCC, experience 10 years of cancer-specific survival. The quality of life after treatment is therefore important. A retrospective study shows that patients experience lower quality of life than expected after surgical treatment of RCC. Patients undergoing radical nephrectomy experience poorer quality of life compared to patients undergoing PN. Surgical complications are considered to interfere with quality of life after PN and Cryo is considered a much gentler treatment with a lower complication rate. To our knowledge there has been no research addressing the impact of Cryo on quality of life. 

Purpose

The purpose of this Ph.D. project is to assess and compare clinical outcome and quality of life after Cryo and PN, respectively.

Description of the cohort

Patients > 18 years of age undergoing Cryo of histologically verified primary RCC at stage T1 at Odense University hospital.

Patients > 18 years of age undergoing PN of histologically verified primary RCC at stage T1 at Odense University Hospital and Zealand University Hospital.  

Data and biological material

Questionnaires and clinical data from the elektronic medical journal. 

Collaborating researchers and departments

Department of Radiology, Odense University Hospital

• Associate professor, Ole Graumann, MD PhD
• Post.doc student, Benjamin Rasmussen, MD PhD

Department of Public Health, University of Southern Denmark

• Associate professor, Birgitte Nørgaard, PhD

Department of Urology, Zealand University Hospital

• Clinical associate professor, Nessn Asawi, MD PhD

Department of Urology, Odense University Hospital

• Professor Lars Lund, MD DMSciDepartment of Radiology, Odense University Hospital
• Associate professor, Ole Graumann, MD PhD
• Post.doc student, Benjamin Rasmussen, MD PhD