Endoscopic Robot-Assisted Simple Enucleation Versus Standard Robot-Assisted Partial Nephrectomy in the Treatment of T1 Renal Cell Carcinoma: A Non-inferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Rates of positive surgical margin
研究概览
简要总结
This is a non-inferiority, randomized controlled trial to compare the peri-operative, renal functional and oncologic outcomes of endoscopic robot-assisted simple enucleation(ERASE) and standard robot-assisted partial nephrectomy(RAPN) in the treatment of T1 renal cell carcinoma.
详细描述
Simple enucleation (SE) consists of excising the tumor by blunt dissection following the natural cleavage plane between the peritumoral capsule and the renal parenchyma without removing a visible rim of healthy renal tissue, which appears to reserve more renal parenchyma without compromising oncologic safety, may be an alternative to standard partial nephrectomy (PN). Although published studies showed excellent long-term oncologic results, many urologists still consider SE an unsafe technique with a high risk of incomplete tumor excision. The aim of this study is to compare the peri-operative, renal functional and oncologic outcomes of endoscopic robot-assisted simple enucleation(ERASE) and standard robot-assisted partial nephrectomy(RAPN) in the treatment of T1 renal cell carcinoma.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Mask to participant and outcomes assessor.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma
- •ECOG score <=1
- •RENAL score <=9
- •patients with normal contralateral renal function
- •patients giving consent to the participation in the current clinical trial
排除标准
- •intolerance of robotic surgery
- •metastastic renal cell carcinoma
- •RENAL score >=10
- •entry into collection system or hematuria
- •patients with a history of other renal diseases, such as urinary lithiasis
- •patients with a history of renal surgery
结局指标
主要结局
Rates of positive surgical margin
时间窗: 10 days post surgery
次要结局
- absolute change in estimated glomerular filtration rate(eGFR)(baseline, 3 months and 12 months)
- warm ischemic time(during surgery)
- hilar clamping, entry into sinus, suturing tumor bed(during surgery)
- absolute change in glomerular filtration rate (GFR) of the affected kidney measured by renal scintigraphy(baseline, 3 months and 12 months)
- 5-year Progression-free survival(5 to 7 years)
- blood loss(during surgery)
- operation time(during surgery)
- intraoperative and postoperative complications(up to 6 months)
研究者
Hongqian Guo
Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School