Resection or Ablative Treatment of Small Renal Tumors, a Multicenter Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Radiological signs of a residual tumor at the 6-month follow-up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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"
排除标准
- •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
结局指标
主要结局
Radiological signs of a residual tumor at the 6-month follow-up
时间窗: 6-month after inclusion
Radiological sign of residual tumor at 6-month radiology
Number of participants with surgical complications according to Clavien-Dindo grade 2-5
时间窗: 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.
Number of postoperative hospitalization days (LOS)
时间窗: 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.
次要结局
- Overall survival (OS)(2, 5 and 10 years after inclusion)
- Cancer-specific survival (CSS)(2, 5 and 10 years after inclusion)
- Change in eGFR one year after treatment(One year after inclusion)
研究者
Anders Kjellman
Associate Professor
Karolinska University Hospital