Prospective Evaluation of Opiate Use Status in Patients Referred for Endoscopic Evaluation of Bile Duct Dilation
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Identification of factors associated with biliary dilation
研究概览
简要总结
We hope to better define the association between opiate use and biliary dilation, which was evident in our previous retrospective study. This prospective study including all endoscopic ultrasound procedures performed for further evaluation of biliary dilatation in the setting of bilirubin <2 mg/dL will enable accurate measurement of common bile duct and pancreatic duct diameter using endoscopic ultrasound and identification of other non- obstructive factors which may modulate biliary dilation (i.e. age, cholecystectomy status, duration and type of opiate used).
详细描述
We hope to better define the association between opiate use and biliary dilation, which was evident in our previous retrospective study. This prospective study including all endoscopic ultrasound procedures performed for further evaluation of biliary dilatation in the setting of bilirubin <2 mg/dL will enable accurate measurement of common bile duct and pancreatic duct diameter using endoscopic ultrasound and identification of other non- obstructive factors which may modulate biliary dilation (i.e. age, cholecystectomy status, duration and type of opiate used).
We believe this work will be of great interest to gastroenterologists, as it provides additional data for interpretation of isolated common bile duct dilation in asymptomatic patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referral/consultation for consideration for EUS ± ERCP
- •Age 18 and older
- •Evidence of biliary dilation on abdominal imaging without obstructive pattern on liver function tests or imaging.
- •Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
排除标准
- •Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
- •Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
- •Other biliary process which accounts for patient's abnormal liver function studies/imaging (i.e. mass, stone, cirrhosis).
结局指标
主要结局
Identification of factors associated with biliary dilation
时间窗: Up to 3 hours
Statistical analysis will be conducted to assess for association between opiate use (including type and duration of opiates) and common bile duct diameter. We will also evaluate for other factors predictive of increased common bile duct diameter, which may include age and cholecystectomy status (based on our initial retrospective study). Power calculations to determine sample size were extrapolated from the initial retrospective study at our institution.
Identification of factors associated with pancreatic duct dilation
时间窗: Up to 3 hours
Statistical analysis will be conducted to assess for association between opiate use (including type and duration of opiates) and common bile duct diameter. We will also evaluate for other factors predictive of increased common bile duct diameter, which may include age and cholecystectomy status (based on our initial retrospective study). Power calculations to determine sample size were extrapolated from the initial retrospective study at our institution.
次要结局
未报告次要终点
研究者
Subhas Banerjee
Associate Professor of Medicine
Stanford University