Resection or Ablation of Small Kidney Tumors

Trial Title: Resection or Ablation of Small Kidney Tumors

NCT ID: NCT06278506

Condition: Kidney Cancer

Conditions: Official terms:
Kidney Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: RCT

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Ablation
Description: Microwave ablation, Radiofrequency ablation, Cryo ablation
Arm group label: Ablation

Other name: Microwave ablation, Radiofrequency ablation, Cryo ablation

Intervention type: Procedure
Intervention name: Surgery
Description: Partial or total nefrectomy
Arm group label: Partial nephrectomy

Other name: Partial nefrectomy, total nefrectomy

Summary: 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.

Detailed description: 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. 3. Hypothesis 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. 4. Outcome Measures 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

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Age 18 - 99 years - Patient suitable based on clinical status for both ablative treatment and surgery - Primary kidney tumor - Tumor size ≤ 3 cm - Clinical stage of the tumor T1a (no macroscopic vascular or extrarenal invasion) - Tumor location suitable for both ablative treatment and resection - Absence of radiological signs of metastasis - Biopsy with malignant pathological analysis (PAD) - ISUP grade I-III" Exclusion Criteria: - Radiological signs of metastasis - Synchronous kidney tumors - ISUP grade IV or sarcomatoid growth in the biopsy - Other metastasized cancer in the last 5 years - Patient unable to make an informed decision to participate in the study

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Locations:

Facility:
Name: Karolinska University Hospital

Address:
City: Stockholm
Zip: 14186
Country: Sweden

Status: Recruiting

Contact:
Last name: Anders Kjellman, MD, PhD

Phone: +46736995258
Email: anders.kjellman@regionstockholm.se

Contact backup:
Last name: Per-Olof Lundgren, MD, PhD

Start date: January 31, 2024

Completion date: December 2037

Lead sponsor:
Agency: Karolinska University Hospital
Agency class: Other

Source: Karolinska University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06278506