Opiate Use and Biliary Dilation

Prospective Evaluation of Opiate Use Status in Patients Referred for Endoscopic Evaluation of Bile Duct Dilation

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).

Study Overview

• Status: Unknown
• Conditions: Evaluation of Association Between Opiate Use and Biliary Dilation
• Intervention / Treatment: Diagnostic test: Endoscopic ultrasound

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Recruiting
      • Stanford University Medical Center
      • Contact: Subhas Banerjee; Phone Number: 650-723-2623; Email: sbanerje@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Biliary Dilation Cohort; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: March 8, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: March 8, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: 45243

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No