N/A
N=327
Prospective Evaluation of Biliary Tissue Sampling With ERCP
Cholangiopancreatography, Endoscopic Retrograde · Biliary Stricture · Biliary Tract Diseases · Cholangiocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT04572711 ↗Enrolled (actual)
327
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Performance Characteristics — 84.09; 56.98; 94.87 Percentage
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Performance Characteristics |
84.09; 56.98; 94.87 | — |
| PRIMARY Number of Adverse Events |
— | — |
| PRIMARY Positive and Negative Predictive Value |
81.5; 84.1 | — |
| SECONDARY Healthcare Utilization |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adults > 18 years
- Diagnosis of indeterminate biliary stricture
- Scheduled clinically indicated ERCP procedure
Exclusion Criteria
- Adults <18 years, Children
Data sourced from ClinicalTrials.gov (NCT04572711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.