Karolinska University Hospital
Stockholm, 14186, Sweden
Location status: Recruiting
NCT Number: NCT06278506
Ablative treatments are believed to have a lower rate of complications, shorter hospital stays, and fewer interventions with benign PAD compared to partial nephrectomies in small kidney cancer lesions. The purpose of the study is to compare complications, the frequency of residual tumors, impact on kidney function, differences in quality of life, and health economic factors in a randomised study. We will also compare the oncological outcomes, including survival and recurrence of kidney cancer.
Interested in participating?
Request Info18 year–99 year
All sexes
Interventional
Not applicable
Stockholm, 14186, Sweden
Location status: Recruiting
Kidney cancer represents approximately 2-3% of all cancer cases, with about 400,000 new cases and 175,000 deaths worldwide in 2018. In Sweden, about 1,200 new cases of kidney cancer are detected each year. The most common age for diagnosis is between 60 and 80 years, and it is more prevalent in men than in women. Many cases are incidentally discovered during imaging studies for unrelated issues. There has been an increase in incidentally detected tumors in Sweden, from 43% in 2005 to 69% in 2021. Nephron-sparing surgery, i.e., partial nephrectomy, is recommended for preserving kidney function in localized tumors.
Ablative treatments are recommended for patients with significant comorbidities, multiple tumors, a single kidney, or other situations where surgery is not considered suitable. Prior to treatment, a biopsy is usually performed to confirm the diagnosis. Studies show variations in oncological outcomes based on the subgroups of kidney cancer treated with ablative techniques. Ablative techniques seem to have a lower risk of complications compared to surgery concerning perioperative complications, bleeding, and maintaining kidney function for a longer time. However, there are no randomized controlled studies comparing ablative treatment with nephrectomy for T1a tumors in the kidney.
Ablative treatment of small kidney tumors may result in shorter hospital stays with fewer complications compared to surgical resection.
There is no difference in long-term oncological outcomes between the methods.
The primary purpose of the study is to compare surgical complications, findings of remaining tumors after primary treatment, and the time patients are hospitalized after each procedure. Secondary outcomes include oncological outcomes in the short and long term, as well as functional factors
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Microwave ablation, Radiofrequency ablation, Cryo ablation
Other names: Microwave ablation, Radiofrequency ablation, Cryo ablation
Partial or total nefrectomy
Other names: Partial nefrectomy, total nefrectomy
Time frame: First year after inclusion
recorded through chart review at 30 and 90 days after treatment. Complications are summed up in case of retreatment before the 12-month follow-up.
Time frame: 6-month after inclusion
Radiological sign of residual tumor at 6-month radiology
Time frame: Sum of total after all interventions first year after the first intervention
Number of postoperative hospitalization days (LOS), i.e., the time the patient has been hospitalized after the procedure until discharge. Hospitalization time is accumulated in case of retreatment within 12 months.
Time frame: 2, 5 and 10 years after inclusion
Cancer-specific survival (CSS) is the period from cancer diagnosis to death caused by this cancer diagnosis. CSS will be calculated using Kaplan-Meier estimates and cumulative incidence of cancer-specific death.
Time frame: 2, 5 and 10 years after inclusion
State of survival
Time frame: One year after inclusion
The study aims to assess kidney function impairment one year after treatment. Blood tests for estimated glomerular filtration rate (eGFR) will be compared with preoperative values to monitor changes. Impaired function is defined as eGFR reduction by ≥20% one year after the procedure compared to measurements before treatment for kidney tumors (10).
Contact information is provided by the study sponsor or research team.
Karolinska University Hospital
Other
Resection or Ablative Treatment of Small Renal Tumors, a Multicenter Randomized Clinical Trial
Acronym: RESTART
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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