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临床试验/NCT04556396
NCT04556396已完成不适用

Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy

Loyola University2 个研究点 分布在 1 个国家目标入组 234 人开始时间: 2020年6月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
234
试验地点
2
主要终点
"Second Look" Rate

研究概览

简要总结

Percutaneous nephrolithotomy (PCNL) is a first-line treatment for kidney stones >2cm. Frequently, patients require multiple procedures to address their stone burden. The decision to proceed with a second-look procedure is based on follow-up CT imaging, which is obtained postoperatively. In this study, we propose the use of a portable CT scan technology to obtain follow-up imaging while the patient is still under anesthesia for the initial procedure. The goal of this study is to determine whether this allows the surgeon to identify residual fragments and render the patient stone-free within a single anesthetic event.

详细描述

Percutaneous nephrolithotomy (PCNL) is considered a first-line management option for kidney stones larger than two centimeters. Unfortunately, because of the large stone burden, up to 70% of these patients are left with residual stone fragments after their initial PCNL. Additionally, an estimated 20% to 60% of such patients ultimately require further interventions due to residual stone fragments. The need for a subsequent procedure is determined by postoperative abdominal computed tomography (CT) imaging, which is routinely performed on the first postoperative day at this institution. The decision to proceed with a second procedure is based on findings from this postoperative CT scan.

Cone-beam CT (CBCT) is a novel portable imaging technique that can allow cross-sectional imaging to be obtained intraoperatively, rather than post-operatively. Incorporating this modality would allow the surgeon to determine whether the procedure should be continued, in the event of residual fragments, or if it can be safely concluded. This would obviate the need for dedicated postoperative CT scans and, more importantly, reduce the need for subsequent procedures and consequently decrease the patient's length of stay.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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

入选标准

  • Patients >18 years old
  • Scheduled for percutaneous nephrolithotomy with stone fragmentation (laser/ultrasonic/mechanical)
  • For the prospective intervention arm, willingness to consent to participate in the study

排除标准

  • Patients whose habitus does not allow for the use of the cone beam CT machine
  • Patients whose stones only reside within the mid or distal ureter(s) and thus would not be easily imaged with cone beam CT
  • Patients who have had lithotripsy on their renal unit within the prior 90 days
  • Pregnant patients

结局指标

主要结局

"Second Look" Rate

时间窗: 90 days

The percentage of patients requiring subsequent surgical intervention to remove residual stones

次要结局

  • Surgical Complication Rate(90 days)
  • "Stone Free" Rate(90 days)
  • Reobstruction Rate(90 days)
  • Hospital Length of Stay(90 days)

研究者

发起方
Loyola University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristin Baldea

MD, Assistant Professor Of Urology

Loyola University

研究点 (2)

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