ClAmpless, Sutureless PartIAl Nephrectomy for Renal Masses (CASPIAN)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Positive margin rate
研究概览
简要总结
During partial nephrectomy surgery, efforts at minimizing ischemia while maximizing renal parenchymal volume are desirable to preserve renal function1,2. Not only clamping of the hilum but the renorrhaphy portion of the procedure also can have a significant negative impact on renal function3-5. It is possible to perform this procedure without clamping the hilum and also without formal renorrhaphy. However robust prospective formal evaluation of safety, risks, and potential benefits and whether or not the technique can be employed in a generalized fashion has not been studied.
Demonstration of safety and generalizability may open a whole new avenue of approaching nephron sparing and renal function sparing kidney surgery and decrease potential risks for long term kidney disease in patients with renal masses. This study will investigate the safety, efficacy, and generalizability of the use of clampless, sutureless partial nephrectomy in the treatment of renal cell carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adults ≥ 18 years of age.
- •Patients undergoing partial nephrectomy for renal masses ≤ 7 cm
- •Subjects must not have more than one active malignancy at the time of enrollment. (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen [as determined by the treating physician or approved by the Principal Investigator] may be included).
- •A clinical diagnosis consistent with renal cell carcinoma, cT1-3 N0 M0 without renal vein thrombus.
- •Adequate laboratory test results, including:
- •Platelets > 50,000/µL
- •Hemoglobin > 9.0 g/dL
- •Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.
- •Subjects of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 2 weeks after surgery to minimize the risk of pregnancy. Prior to study enrollment, subjects of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
- •Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 2 weeks following surgery.
排除标准
- •Bleeding disorder (any congenital bleeding diathesis)
- •Liver dysfunction with end stage liver disease as determined by the treating investigator
- •Presence of renal vein thrombus
- •End stage renal disease (eGFR < 15 using Cockcroft-gault formula or receiving renal replacement therapy (i.e. dialysis))
- •Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 2 weeks after surgery.
- •Subjects who are confirmed to be pregnant or breastfeeding.
- •History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
- •Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
研究组 & 干预措施
Clampless, sutureless robotic partial nephrectomy
干预措施: sutureless, clampless partial nephrectomy (Procedure)
结局指标
主要结局
Positive margin rate
时间窗: 2-3 weeks post-surgery
Determine the positive margin rate, as measured on the pathology report 2-3 weeks post-surgery.
Transfusion rate
时间窗: 4 weeks post-surgery
Determine the transfusion rate, as measured approximately 4 weeks post-surgery via review of patient medical records.
次要结局
- Renal dysfunction (1 day post-surgery)(1 day post-surgery)
- Renal dysfunction (2-3 weeks post-surgery)(2-3 weeks post-surgery)
- Renal dysfunction (6 months post-surgery)(6 months post-surgery)
- Estimated blood loss(at time of partial nephrectomy)
- Need for ischemia(at time of partial nephrectomy)