Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Radiation exposure dose
研究概览
简要总结
This study will be a randomized controlled study comparing the use of two clinical management strategies in nephrostomy tube management following percutaneous nephrolithotomy (PCNL). The first strategy entails using contrast-enhanced ultrasound (CEUS) to evaluate the renal collecting system (1). This is a new imaging approach applying ultrasound machines with special software in combination with intraluminal ultrasound contrast agent (Lumason) injection, which is an FDA-approved ultrasound contrast agent (2). The second strategy is a nephrostomy tube capping trial combined with low dose non-contrast computed tomography (CT) scan, one of the most frequently utilized clinical management strategies currently used in clinical practice (3).
详细描述
This is a multi-center, randomized controlled study comparing the use of CEUS to CT scan plus capping trial immediately following PCNL. A total recruitment target of 1,046 subjects is planned and participants will be randomized into one of the two study arms.
- Contrast-enhanced ultrasound (CEUS) arm: On postoperative day 1 (unless not clinically indicated), each subject will undergo CEUS with an administration of Lumason via their pre-placed nephrostomy tube.
- Non-contrast CT scan plus capping trial arm: On postoperative day 1 (unless not clinically indicated), subjects' pre-placed nephrostomy tube will be capped and they will undergo a low dose non-contrast abdominal CT scan.
Subsequently, nephrostomy tubes will be managed based on the results from these studies by the treating surgeon.
Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
The following investigational regimen will be used only in the CEUS arm:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Care Provider, Investigator)
盲法说明
The surgical team will be blinded to the randomization outcome of the patient until the day after surgery so as to minimize any bias introduced into their preoperative counseling. After that point, treatment teams will no longer be blinded to randomization.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 years or older.
- •Renal and/or ureteral stone of any size diagnosed either by ultrasound or CT scan and requiring surgical treatment with percutaneous removal (PCNL).
排除标准
- •A second stage PCNL is planned or expected after surgery, entailing that postoperative tube management is pre-determined.
- •Subjects with serious illness likely to cause death within the next 5 years, so as to exclude significant metabolic derangements that might lead to adverse surgical outcome.
- •Subjects with a history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason
- •Pregnancy, which is a contraindication to both CT scan and ultrasound contrast injection.
研究组 & 干预措施
CEUS arm
On postoperative day 1 (unless not clinically indicated), each subject will undergo CEUS with an administration of Lumason via their pre-placed nephrostomy tube.
干预措施: CEUS (Drug)
CT scan plus capping trial arm
On postoperative day 1 (unless not clinically indicated), subjects' pre-placed nephrostomy tube will be capped and they will undergo a low dose non-contrast abdominal CT scan.
干预措施: Non-contrast CT scan (Diagnostic Test)
CT scan plus capping trial arm
On postoperative day 1 (unless not clinically indicated), subjects' pre-placed nephrostomy tube will be capped and they will undergo a low dose non-contrast abdominal CT scan.
干预措施: Capping trial (Diagnostic Test)
结局指标
主要结局
Radiation exposure dose
时间窗: 6 months following surgery
For radiation exposure dose measurement in this study, the investigators will use dose metrics obtained from the Digital Imaging and Communications within the scanners or Picture Arching and Communication system (PACS).
次要结局
- Rate of adverse clinical events(6 months following surgery)
研究者
Thomas Chi, MD
Assistant Professor
University of California, San Francisco