Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Renal function
研究概览
简要总结
This study evaluates novel surgical approach in treating small renal masses. Half of participants will undergo hypotonic zero-ischaemia partial nephrectomy (standard of care), while the other half will undergo normotonic zero-ischaemia partial nephrectomy (experimental method).
详细描述
Partial nephrectomy is believed to be the gold standard for treating small renal masses (SRM). The warm ischaemia and hypotonic zero-ischaemia approach are widely used techniques of care. But they have some negative effects according to renal function (RF) after surgery. We decided to compare influence of arterial blood pressure (normotension or hypotension) during partial nephrectomy on RF.
A single-center prospective study comparing normotonic and hypotonic partial nephrectomy will be conducted.
The design involves random allocation of eligible patients to normotonic or hypotonic partial nephrectomy group in 1:1 ratio.
Experimental group - normotonic partial nephrectomy (avoidance of hypotension: mean blood pressure more or equal 65 mm Hg).
Control group - hypotonic partial nephrectomy (using medical hypotension; avoidance of hypertension: mean blood pressure less than 65 mmHg
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected by computed tomography or another instrumental method renal mass
- •Clinical stage T1-2N0-2M0-1 (distant metastases must be resectable)
- •Indications for partial nephrectomy
- •Eastern Cooperative Oncology Group status 0-2
- •At least 18 years of age
- •Written informed consent
排除标准
- •Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol
- •Pregnancy or breast feeding
- •Medical contraindications for surgical treatment
- •Synchronous or metachronous malignancy
- •Non-resectable distant metastases
- •The patient's refusal to perform research procedures.
- •Refusal of the patient to continue participation in the study.
结局指标
主要结局
Renal function
时间窗: within the first 3 month after surgery
glomerular filtration rate calculation (mL/min), nephroscintigraphy
Blood loss
时间窗: enrollment
Volume of intraoperative blood loss (ml)
次要结局
- Disease-free survival(1 year after last patient enrolled)
- Resection margins status(enrollment)
研究者
Vladislav Osetnik
Principal Investigator
Saint Petersburg State University, Russia