Oncological and Functional Outcomes of Laparoscopic Partial Nephrectomy in Renal Cell Carcinoma Stages T1 Versus T2a: Prospective Comparative Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Renal function.
研究概览
简要总结
RCC represents around 3% of all cancers, with the highest incidence occurring in Western countries . Within the several RCC risk factors identified, smoking, obesity, and hypertension are most strongly associated with RCC .
The EUA guidelines recommend PN for patients with T1 tumors, as PN preserved kidney function better after surgery, thereby potentially lowering the risk of development of cardiovascular disorders as well as improving overall survival(OS) for PN compared to RN, there is very limited evidence on the optimal surgical treatment for patients with larger renal masses (T2) .
Currently, the upper limit of PN indications remains undefined and is determined by an individual surgeon's expertise and preference. The degree of variability in the choice between PN and RN for a given tumor increases with tumor size. Surgeons committed to nephron-sparing are likely to expand the indications of PN, while those concerned with increased morbidity and doubtful of the clinical relevance of a moderate decrease in renal function are likely to perform RN, regardless of tumor size .
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with localized RCC ≤ 10 cm in preoperative contrast enhanced imaging(T1 and T2a).
排除标准
- •Patients who had other tumors
- •benign tumors
- •clinically unfit
- •metastatic RCC
- •patients with Clinical T2b or higher tumors,
- •tumors with maximum diameter > 10cm
结局指标
主要结局
Renal function.
时间窗: 3month
Patients' pre and postoperative eGFR values were calculated using the Chronic Kidney Disease Epidemiology Collaboration equation, with the postoperative eGFR based on the creatinine measurement taken closest to 1 yr after surgery (between 9 and 15 month postoperatively). The eGFR downgrade was defined as preoperative eGFR 60 ml/min/1.73 m2 and postoperative eGFR \<60 ml/min/1.73 m2 at 1 yr after surgery.
Post-operative complications.
时间窗: 3 month
complications within 90 days of operation were prospectively collected and classified based on the modified Clavien -Dindo grading system
Local recurrence.
时间窗: 3 month
radiological investigation in the form of contrast enhanced CT abdomen and pelvis or MRI incase of raised serum creatinine
Distant metastases.
时间窗: 3 month
radiological investigation in the form of contrast enhanced CT abdomen and pelvis or MRI incase of raised serum creatinine and bone scan incase of bone pain or pathological fractures CT BRAIN incase of manifestation of increased intracranial tension
次要结局
未报告次要终点
研究者
Ahmed Mahmoud Attia
assistent lecturer at urology department
Sohag University