NCT02492685撤回不适用
Quantificational Enhancement Pattern Analysis Using a Novel Software "Vuebox" of Contrast-enhanced Harmonic Endoscopic Ultrasonography for Differential Diagnosis Between Adenomas and Cholesterol Polyps
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Accuracy between visual assessment and quantificational analysis based on surgical pathology
研究概览
简要总结
The investigators' study is a prospective study to evaluate the enhancement pattern of contrast-enhanced endoscopic ultrasonography and suggest the criterions for differential diagnosis between gallbladder polyps by using software program of quantitative analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient who will be received the exams to evaluate the polyps for treatment plan of surgical treatment
- •have a plan to evaluate by EUS
- •19 years of age or older
排除标准
- •difficult undergo EUS,
- •allergy for contrast agent,
- •renal failure,
- •acute coronary syndrome
- •pulmonary hypertension, 6) pregnancy
研究组 & 干预措施
Contrast enhanced EUS group
Experimental
Contrast enhanced EUS with quantitative analysis
干预措施: Quantitative analysis by using the new developed software program VueBox (Device)
结局指标
主要结局
Accuracy between visual assessment and quantificational analysis based on surgical pathology
时间窗: 1day
次要结局
- Specificity between visual assessment and quantificational analysis based on surgical pathology(1 day)
- Sensitivity between visual assessment and quantificational analysis based on surgical pathology(1 day)
- NPV between visual assessment and quantificational analysis based on surgical pathology(1 day)
- PPV between visual assessment and quantificational analysis based on surgical pathology(1 day)
研究者
研究点 (2)
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