Biopsy Protocol of Upper Gastrointestinal Subepithelial Tumors:Diagnostic Accuracy of EUS-FNB Versus Unroofing Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- diagnostic accuracy
研究概览
简要总结
To increase the diagnostic accuracy of subepithelial tumors, larger tissue samples are required. It is difficult to obtain adequate tissue samples. There were several biopsy methods to obtain tissue samples. Pathological examination would include mitosis counts, particularly in hypoechoic subepithelial tumors located in the 4th layer of the gastric wall, where differentiation between leiomyoma of benign nature and gastrointestinal stromal tumor (GIST) of malignant potential is essential.
So We hypothesize that unroofing biopsy is an more appropriate method than EUS-FNB(endoscopic ultrasonography guided fine needle biopsy). We will compare diagnostic accuracy and complications between EUS-FNB & unroofing biopsy.
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
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 19 years old and younger than 80 years old
- •Suspected upper gastrointestinal subepithelial tumors(≥15mm, ≤35mm) that were originated from muscularis propria layer on endoscopic ultrasonography(EUS)
排除标准
- •Patient who had bleeding tendency
- •Any previous surgery on esophagus, stomach or duodenum
- •Patients who can not be underwent sedated endoscopy
- •Gastrointestinal subepithelial tumor that was not origianted from muscularis propria layer on EUS
- •Constrast related allergic disease
结局指标
主要结局
diagnostic accuracy
时间窗: within 7 days
We will compare between diagnostic accuracy of EUS-FNB \& unroofing biopsy using final histopathological result.
次要结局
- number of complications of procedure(within 7 days)
- accuracy of malignant potential on contrast enhanced EUS(within 7 days)