EUS-Endodrill vs. EUS-FNA for Diagnosis of Submucosal Tumors in the Upper GI Tract
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Region Skane
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Number of correct histopathological diagnoses from submucosal tumors in the upper GI tract.
研究概览
简要总结
Endodrill is a new instrument for biopsy sampling in the GI-channel. The purpose of this study is as follows:
- Compare EUS-guided Endodrill biopsies with endoscopic ultrasound guided fine needle aspiration (EUS-FNA) in terms of ability to establish the correct diagnosis of submucosal tumors in the upper GI tract.
详细描述
Endodrill is a newly constructed biopsy tool for flexible endoscopic use. It uses a drilling motion within a casing to harvest solid biopsies from tissue through the biopsy channel of a conventional flexible endoscope. It was originally designed for sampling of tissue from submucosal lesions. The investigators first study of the instrument is now finished. Endodrill is safe to use and generates more submucosal tissue compared to biopsies with a conventional biopsy forceps.
In this study the investigators want to compare the Endodrill instrument with FNA (both modalities EUS-guided) in terms of ability to obtain the correct diagnosis of submucosal tumors in the upper GI-tract. Patients diagnosed with suspected submucosal tumors in the upper GI-tract will be enrolled to this study. They will first go through examination with EUS. If the suspicion of a submucosal tumor is confirmed, the investigator will perform both EUS guided FNA and Endodrill biopsies in the same patient.The harvested tissue will be evaluated by senior pathologists to clarify which method that generates most correct diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with a suspected submucosal tumor in the upper GI tract that are available for both EUS-guided FNA and Endodrill biopsy
排除标准
- •Mental illness
- •Extreme co-morbidity
结局指标
主要结局
Number of correct histopathological diagnoses from submucosal tumors in the upper GI tract.
时间窗: 24 months
Number of biopsies with the correct histopathological diagnoses
次要结局
未报告次要终点
研究者
Martin Jeremiasen
Consultant Surgeon
Region Skane
