Opiate Use and Biliary Dilation

• Conditions: Evaluation of Association Between Opiate Use and Biliary Dilation
• Interventions: Diagnostic Test: Endoscopic ultrasound

• Registration Number: NCT03870347
• Lead Sponsor: Stanford University

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2018-01-03
• Status Verified: 2019-03
• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-08
• Last Update Submitted: 2019-03-08
• Study First Posted: 2019-03-12
• Last Update Posted: 2019-03-12
• Primary Completion: 2021-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Referral/consultation for consideration for EUS ± ERCP
2. Age 18 and older
3. Evidence of biliary dilation on abdominal imaging without obstructive pattern on liver function tests or imaging.
4. Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria

1. Age <18
2. Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
3. Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
4. Other biliary process which accounts for patient's abnormal liver function studies/imaging (i.e. mass, stone, cirrhosis).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biliary Dilation Cohort	Endoscopic ultrasound	Patients referred for endoscopic evaluation of biliary dilation

Primary Outcome Measures

Name	Time	Method
Identification of factors associated with biliary dilation	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	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.

Trial Locations

Locations (1)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States