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临床试验/NCT02075684
NCT02075684已完成不适用

Office-based Percutaneous Ultrasound-guided Renal Biopsy

University of California, Irvine2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Tumor Characteristics

研究概览

简要总结

The purpose of this research study is to create a prospectively maintained, multicenter database of patients undergoing renal biopsy for renal masses performed percutaneously (through skin), via an 18 gauge biopsy needle (.048 inches). In this database, the investigators will collect and maintain the data from the biopsy procedure. This will allow us to evaluate our experience with this procedure as well as to participate in multi-institutional collaborative studies in the future. At University of California Irvine, the investigators routinely biopsy patients with renal masses under real-time ultrasound control. Percutaneous renal biopsy under ultrasound guidance is a routine procedure performed to diagnose renal mass histopathology. The safety and efficacy of this procedure has been well documented in the literature. The indications for percutaneous renal biopsy have expanded as there has been a substantial increase in the number of renal masses that are being diagnosed, and the acceptance of percutaneous biopsy continues to expand in parallel. The biopsy procedure is part of your normal standard of care and if not being done for this research project.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • Must be undergoing standard percutaneous renal biopsy
  • Patients must be ≥18 years of age
  • Must be able to understand and render voluntary, written informed consent

排除标准

  • Patients <18 years of age
  • Pregnant women
  • Coagulopathy
  • Active urinary tract infection

结局指标

主要结局

Tumor Characteristics

时间窗: Baseline

Tumor characteristics will be recorded at Baseline (from preoperative imaging) using the R.E.N.A.L. Nephrometry scoring system which captures tumor radius (R), depth within renal parenchyma (E), nearness to collecting system (N), anterior/posterior location (A) and polarity (L).

次要结局

  • Verbal analog pain scale(Baseline, 1 hour post procedure, and 3 days - 3 weeks post-procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaime Landman

Professor of Urology and Radiology

University of California, Irvine

研究点 (2)

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