Recruiting

Observational Study

Sponsor:

Stanford University

Code:

NCT03870347

Conditions

Evaluation of Association Between Opiate Use and Biliary Dilation

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Endoscopic ultrasound

Study Details

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

Study ID

NCT03870347

Start date

Jan 3, 2018

Status verified date

Mar, 2019

Completion date

Jan, 2022

Anticipated

Primary completion date

Jan, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Biliary Dilation Cohort

Patients referred for endoscopic evaluation of biliary dilation

Interventions

Endoscopic ultrasound

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

Primary outcome measure

  • Identification of factors associated with biliary dilation [ Time Frame: Up to 3 hours ]
  • Identification of factors associated with pancreatic duct dilation [ Time Frame: Up to 3 hours ]

Central Contacts and Locations

Locations

Stanford University Medical Center

Recruiting

Stanford, California, United States, 94304

Contacts

Subhas Banerjee

650-723-2623sbanerje@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Mar 12, 2019

Last verified

Mar, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2019-03-12.