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
327
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Performance Characteristics
Accuracy, Sensitivity, Specificity for the detection of malignancy with each sampling technique. Accuracy was calculated as \[(true positives + true negatives)/ (true positives + true negatives + false positives + false negatives)\] x100 and reported as a percentage. Sensitivity was calculated as \[true positive/(true positive + false negative)\] x100 and reported as a percentage. Specificity was calculated as \[true negatives/(true negatives +false positives)\] x100 and reported as a percentage.
Time frame: 1 year after ERCP procedure
Number of Adverse Events
Adverse events after biliary sampling
Time frame: Within 30 days of ERCP procedure
Positive and Negative Predictive Value
Positive Predictive Value calculated as number of true positives divided by the sum of true positives and false positives, expressed as a percentage. Negative predictive value calculated as the number of true negatives divided by the sum of true negatives and false negatives, expressed as a percentage.
Time frame: 1 year after ERCP procedure
Healthcare Utilization
Number of ERCPs, Radiological studies etc needed before accurate diagnosis
Time frame: through study completion, an average of 2 years
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