Establishing Standards for Normal Pancreatic EUS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Number of Patients with Hyperechoic Foci
研究概览
简要总结
There is tremendous variability in regard to provider perception of findings on EUS for chronic pancreatitis. This study performs tandem EUS exams between expert endosonogrpahers to determine the validity of minimal standard criteria.
详细描述
Chronic pancreatitis is a very challenging disease to diagnose as their is no gold standard for diagnosis. Increasingly, endoscopic ultrasound (EUS) has been used as a means of diagnosing chronic pancreatitis. However, there are questions about whether intra-rater reliability and/or validity are high enough to warrant using EUS to make the diagnosis of chronic pancreatitis.
The purpose of this observational study is to determine the degree of correlation between two expert endosonographers in evaluating minimal standard criteria (MST) in the same patient during the same EUS exam. Patients both with and without chronic pancreatitis will be included in the study to try and determine the validity and reliability of back-to-back EUS examinations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergoing upper EUS for evaluation of the pancreas
排除标准
- •pregnancy
- •age less than 18
- •inability to provide written informed consent
结局指标
主要结局
Number of Patients with Hyperechoic Foci
时间窗: Day 1
Number of Patients with Dilated Dilated Side Branches
时间窗: Day 1
Number of Patients with Ductal Calculi
时间窗: Day 1
Number of Patients with Lobular Contour
时间窗: Day 1
Number of Patients with Cysts
时间窗: Day 1
Number of Patients with Duct Irregularity
时间窗: Day 1
Number of Patients with Hyperechoic Duct Wall
时间窗: Day 1
Number of Patients with Dilated Pancreatic Duct
时间窗: Day 1
Number of Patients with Hyperechoic Strands
时间窗: Day 1
次要结局
未报告次要终点
研究者
Timothy Gardner
Associate Profesor, Department of Medicine
Dartmouth-Hitchcock Medical Center