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OpenTrials
Completed

NCT Number: NCT04572711

Prospective Evaluation of Biliary Tissue Sampling With ERCP

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.

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Key information

Conditions

Cholangiopancreatography, Endoscopic Retrograde Adenocarcinoma Biliary Stricture Biliary Tract Diseases Carcinoma Cholangiocarcinoma Digestive System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults > 18 years
  • Diagnosis of indeterminate biliary stricture
  • Scheduled clinically indicated ERCP procedure

Exclusion criteria

  • Adults <18 years, Children

Treatment and study plan

Primary outcomes

  1. Performance Characteristics

    Time frame: 1 year after ERCP procedure

    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.

  2. Number of Adverse Events

    Time frame: Within 30 days of ERCP procedure

    Adverse events after biliary sampling

  3. Positive and Negative Predictive Value

    Time frame: 1 year after ERCP procedure

    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.

Secondary outcomes

  1. Healthcare Utilization

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

    Number of ERCPs, Radiological studies etc needed before accurate diagnosis

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Oct 1, 2020
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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