Brief Title
Prospective Evaluation of Biliary Tissue Sampling With ERCP
Official Title
Prospective Evaluation of Biliary Tissue Sampling With ERCP
Brief Summary
The purpose of this study is to assess the safety, outcomes and performance characteristics of multiple biliary sampling techniques including but not limited to: single operator cholangioscopy (SOC) directed biopsies, transpapillary biliary biopsies (TPBx), brushings and bile aspiration for cytology and FISH in patients undergoing ERCP.
Study Type
Observational
Primary Outcome
Performance characteristics
Secondary Outcome
Healthcare Utilization
Condition
Cholangiopancreatography, Endoscopic Retrograde
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
500
Start Date
September 1, 2020
Completion Date
May 2026
Primary Completion Date
December 2025
Eligibility Criteria
Inclusion Criteria: - Adults > 18 years - Diagnosis of indeterminate biliary stricture - Scheduled clinically indicated ERCP procedure Exclusion Criteria: • Adults <18 years, Children
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Vinay Chandrasekhara, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04572711
Organization ID
20-004079
Responsible Party
Principal Investigator
Study Sponsor
Mayo Clinic
Study Sponsor
Vinay Chandrasekhara, MD, Principal Investigator, Mayo Clinic
Verification Date
November 2022