Opiate Use and Biliary Dilation

NCT ID: NCT03870347

Last Updated: 2019-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-03
• Study Completion Date: 2022-01-31

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.

Conditions

Evaluation of Association Between Opiate Use and Biliary Dilation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Biliary Dilation Cohort

Patients referred for endoscopic evaluation of biliary dilation

Endoscopic ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Endoscopic ultrasound

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Subhas Banerjee

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University Medical Center

Stanford, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Subhas Banerjee

Role: primary

sbanerje@stanford.edu

650-723-2623

Other Identifiers

45243

Identifier Type: -

Identifier Source: org_study_id