Opiate Use and Biliary Dilation

NCT03870347 | Unknown

• 1 other identifier: 45243
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Evaluation of Association Between Opiate Use and Biliary Dilation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 3 hours

Study Arms (1)

Biliary Dilation Cohort

Patients referred for endoscopic evaluation of biliary dilation

Diagnostic Test: Endoscopic ultrasound

Interventions

Endoscopic ultrasound DIAGNOSTIC_TEST

Upper endoscopy using an echoendoscope to obtain ultrasound images of the pancreaticobiliary system and adjacent structures.

Biliary Dilation Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Age \<18
• 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).

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94304, United States

RECRUITING

MeSH Terms

Interventions

Endosonography

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 12, 2019
• Study Start: January 3, 2018
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2022
• Last Updated: March 12, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)