An observational study in Evaluation of Association Between Opiate Use and Biliary Dilation, sponsored by Stanford University. Status unknown at 1 site in United States. Per ClinicalTrials.gov, last updated 2019-03-12.
Sponsored by Stanford University · Observational
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 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.
260 studies on the registry are indexed under Dilatation, Pathologic; 43 are open to participants now.
This study's planned enrollment of 100 is close to the median of 94 across 64 observational studies indexed under Dilatation, Pathologic.
Browse Dilatation, Pathologic studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
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Patients referred for endoscopic ultrasound (EUS) or endoscopic retrograde cholangiopancreatography (ERCP) for further evaluation of abnormal imaging findings will be screened for inclusion in this study. Patients with biliary dilatation who meet all the inclusion criteria and have none of the exclusion criteria will be invited to participate in this prospective study during their initial clinic visit or hospital consultation.
Exclusion Criteria:
Patients referred for endoscopic evaluation of biliary dilation
Diagnostic Test: Endoscopic ultrasound
Upper endoscopy using an echoendoscope to obtain ultrasound images of the pancreaticobiliary system and adjacent structures.
Identification of factors associated with biliary dilation
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.
Time frame: Up to 3 hours
Identification of factors associated with pancreatic duct dilation
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.
Time frame: Up to 3 hours
Plan to share: No
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This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Stanford University