NCT04506671Unknown不适用
A Prospective, Non-randomized, in Parallel Groups Study Evaluating the Efficacy and Safety of Percutaneous Cryoablation and Partial Nephrectomy in Localized T1b Renal Tumor
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Local recurrence
研究概览
简要总结
The aim of our study is to assess the long-term oncological and functional outcomes of cryoablation for T1b renal tumors, as well as such important parameters as the patient's quality of life after treatment, and to compare the results with those after partial nephrectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CT-confirmed renal mass > 4 to 7 cm (T1b)
排除标准
- •Multiple renal tumors;
- •Recurrence of renal tumor;
- •Intolerance to iodine-containing contrast agents;
- •Pregnancy;
- •Patients with Bosniak 4 cysts
- •Presence of other oncological diseases;
- •Impossibility of organ-preserving treatment due to the proximity of the tumor to the vessels or the calyx-pelvic system
- •Absence of malignant pathology based on prior biopsy.
研究组 & 干预措施
Cryoablation group
Experimental
Patients with T1b renal tumor and ECOQ>20
干预措施: Renal biopsy (Procedure)
Cryoablation group
Experimental
Patients with T1b renal tumor and ECOQ>20
干预措施: Cryoablation (Procedure)
Partial nephrectomy group
Active Comparator
Patients with T1b renal tumor
干预措施: Partial nephrectomy (Procedure)
结局指标
主要结局
Local recurrence
时间窗: 5 years
Local recurrance will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment
次要结局
- Pain score(5 years)
- Renal function(5 years)
- Metastatic progression(5 years)
- Blood loss(12 months)
- Length of hospital stay(1 month)
- Quality of life assessment: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30)(5 years)
- Rate of adverse events(3 months)
研究者
Dmitry Enikeev, MD, PhD
Deputy Director for Research
I.M. Sechenov First Moscow State Medical University
研究点 (1)
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