Contrast-Enhanced Ultrasound vs Conventional US-guided Percutaneous Needle Biopsy for Pancreatic Diseases: Prospective Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy rate
研究概览
简要总结
According to previous studies, contrast-enhanced ultrasound (CEUS) -guided Core Biopsy(GB) could improve the diagnosis of biopsy in liver and other superficial mass compared to conventional US-GB. The purpose of this randomized trial is to estimate whether CEUS-GB achieve excellent diagnostic value to conventional US-GB in percutaneous biopsy for pancreatic diseases.
详细描述
The patients with pancreatic diseases who need receive percutaneous biopsy were randomized with 1:1 ratio into undergo CEUS-GB group and conventional US-GB group.The aims include:
Comparison the diagnostic accuracy rate between CEUS and US group. Comparison the diagnostic specificity, sensitivity and complication rate between CEUS and US group.
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 (Participant, Investigator)
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 ≥18 years, WHO/ECOG scores <2;
- •Radiographic examination reveal focal pancreatic lesions;
- •No history of local treatment for pancreatic lesions, systemic chemotherapy, targeting, immunotherapy, etc;
- •Normal organ function, including the following criteria:
- •Routine blood test: Hb≥80 g/L; PLT≥50×109/L;
- •Coagulation function test: PT<20s.
排除标准
- •The lesions could not be shown by ultrasound and contrast-enhanced ultrasound;
- •Allergic to ultrasound contrast agent;
- •Cardiovascular and cerebrovascular diseases, liver, kidney and lung failure with significant clinical symptoms;
- •History of unexplained bleeding, severe anemia, bleeding tendency or uncorrected coagulopathy;
- •Combined with active infection;
- •Massive ascites;
- •Patients or family members do not agree to enter the study;
- •Pregnant or lactating women;
- •The investigator considers that there are any other factors that may be inappropriate for inclusion or affect the subject's participation in the study.
结局指标
主要结局
Diagnostic accuracy rate
时间窗: 6 month
Diagnostic accuracy rate was defined as the proportion of patients who reached successful diagnosis
次要结局
未报告次要终点
研究者
xiao-yan xie
M.D.
First Affiliated Hospital, Sun Yat-Sen University