ChiCTR2100053443Active, not recruitingEarly Phase 1
CT 三维重建辅助精准建立经皮肾镜取石手术通道的多中心临床研究
自筹35 sites in 1 country200 target enrollmentStarted: November 30, 2021Last updated:
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 35
- Primary Endpoint
- 结石部位
Study Overview
Brief Summary
为使 CT 三维重建辅助精准建立经皮肾镜取石手术通道这一技术能够成为国际化的方法更好地进行临床推广应用拟通过多中心、大样本临床研究的开展，对该手术方法的疗效、安全性和临床实用价值进行客观的评价。
Study Design
- Study Type
- 干预性研究
- Primary Purpose
- 单臂
- Masking
- N/a
Eligibility Criteria
- Ages
- 5 to 80 (—)
- Sex
- All
Inclusion Criteria
- •1.≥2cm 的肾结石、部分鹿角形结石和完全鹿角形结石；
- •2.≥1.5cm 的肾下盏结石；
- •3.输尿管上段嵌顿性结石，包括结石＞1.5cm，结石＜1.5cm 但肾积水严重或体外冲击波治疗失败；
- •4.术前 CT 肾集合系统三维影像重建，集合系统、输尿管显影良好。
Exclusion Criteria
- •1.凝血功能异常未能纠正者；
- •2.因心、脑、肺等合并症不能接受手术者；
- •3.有严重畸形脊柱和肥胖不能俯卧位者；
- •4.尿路感染未能有效控制者；
Arms & Interventions
研究组
CT 三维重建/X 线引导穿刺
Outcomes
Primary Outcomes
结石部位
Time Frame: 术前
患侧
Time Frame: 术前
结石长径
Time Frame: 术前
结石密度
Time Frame: 术前
肾积水
Time Frame: 术前
独肾
Time Frame: 术前
血红蛋白
Time Frame: 术前；术后第一天
血肌酐
Time Frame: 手术前、手术后第一天
尿白细胞数量
Time Frame: 手术前
尿培养
Time Frame: 手术前
穿刺位置
Time Frame: 手术前
目标肾盏
Time Frame: 手术中
通道大小
Time Frame: 手术中
通道数目
Time Frame: 手术中
负压吸引鞘使用情况
Time Frame: 手术中
碎石设备
Time Frame: 手术中
手术时长
Time Frame: 开始穿刺至手术结束
置管情况
Time Frame: 手术中
通道建立成功或失败
体温
Time Frame: 术后第一天
输血
肾动脉栓塞
镇痛剂使用
脓毒血症
邻近器官损伤
尿漏
尿性囊肿
肾周感染
肾切除
死亡
Secondary Outcomes
- 经皮肾镜取石术史(术前)
- 糖尿病史(术前)
- 高血压病史(术前)
- 尿亚硝酸盐(手术前)
- 结石成分
- 无石率
Investigators
Study Sites (35)
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