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Patient Reported Outcome After Nephron Sparing Treatment of Small Renal Tumours

NCT04040530 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 187

Last updated 2023-11-18

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

CT-guided cryoablation

Percutaneous computed tomography guided cryoablation with the patient in sedation or general anaesthesia.

PROCEDURE

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.

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER

  • Region Zealand

    collaborator OTHER

  • Region of Southern Denmark

    lead OTHER

Principal Investigators

  • Theresa Junker, PhD-student · Region of Sourthern Denmark, Odense University Hospital

  • Ole Graumann, MD, PhD · Region of Sourthern Denmark, Odense University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-07
Primary Completion
2021-02-07
Completion
2026-02-07

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04040530 on ClinicalTrials.gov