Resection or Ablation of Small Kidney Tumors
ConditionKidney Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorKarolinska University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 - 99 years
Patient suitable based on clinical status for both ablative treatment and surgery
Primary kidney tumor
Tumor size ≤ 3 cm
Disqualifiers
Radiological signs of metastasis
Synchronous kidney tumors
ISUP grade IV or sarcomatoid growth in the biopsy
Other metastasized cancer in the last 5 years
Trial design
Design model
Parallel
Treatments tested in this trial
Ablation
Procedure/SurgeryMicrowave ablation, Radiofrequency ablation, Cryo ablation
Surgery
Procedure/SurgeryPartial or total nefrectomy
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: AblationExperimental treatment 1 intervention
Group B: Partial nephrectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with surgical complications according to Clavien-Dindo grade 2-5
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
First year after inclusion2
Radiological signs of a residual tumor at the 6-month follow-up
Radiological sign of residual tumor at 6-month radiology
Time frame
6-month after inclusion3
Number of postoperative hospitalization days (LOS)
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
Sum of total after all interventions first year after the first interventionSecondary outcomes
1
Cancer-specific survival (CSS)
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 inclusion2
Overall survival (OS)
State of survival
Time frame
2, 5 and 10 years after inclusion3
Change in eGFR one year after treatment
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).
Time frame
One year after inclusionSponsors and contacts
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Source ClinicalTrials.gov