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NCT04572711 Clinical Trial

Prospective Evaluation of Biliary Tissue Sampling With ERCP

Cholangiocarcinoma Clinical Trial

Official title:
Prospective Evaluation of Biliary Tissue Sampling With ERCP

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04572711
Other study ID # 20-004079
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date May 2026

Study information
Verified date November 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 500
Est. completion date May 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults > 18 years - Diagnosis of indeterminate biliary stricture - Scheduled clinically indicated ERCP procedure Exclusion Criteria: • Adults <18 years, Children

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Performance characteristics Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value for the detection of malignancy with each sampling technique 1 year after ERCP procedure
Primary Number of adverse events Adverse events after biliary sampling Within 30 days of ERCP procedure
Secondary Healthcare Utilization Number of ERCPs, Radiological studies etc needed before accurate diagnosis through study completion, an average of 2 years
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