Prospective Evaluation of Biliary Tissue Sampling with ERCP

N/AEnrolling By InvitationNCT04572711

Mayo Clinic500 enrolled

Overview

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

Enrollment

500

Conditions

Cholangiopancreatography, Endoscopic Retrograde Biliary Stricture Biliary Tract Diseases Cholangiocarcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults \> 18 years * Diagnosis of indeterminate biliary stricture * Scheduled clinically indicated ERCP procedure Exclusion Criteria: • Adults \<18 years, Children

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Performance characteristics

Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value for the detection of malignancy with each sampling technique

Time frame: 1 year after ERCP procedure

Number of adverse events

Adverse events after biliary sampling

Time frame: Within 30 days of ERCP procedure

Secondary Outcomes

Healthcare Utilization

Number of ERCPs, Radiological studies etc needed before accurate diagnosis

Time frame: through study completion, an average of 2 years

Data from ClinicalTrials.gov

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