Prospective Evaluation of Biliary Tissue Sampling with ERCP

• Conditions: Cholangiocarcinoma; Biliary Tract Diseases; Cholangiopancreatography, Endoscopic Retrograde; Biliary Stricture

• Registration Number: NCT04572711
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-25
• Study First Posted: 2020-10-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-12
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

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Exclusion Criteria

• Adults <18 years, Children

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of adverse events	Within 30 days of ERCP procedure	Adverse events after biliary sampling
Performance characteristics	1 year after ERCP procedure	Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value for the detection of malignancy with each sampling technique

Secondary Outcome Measures

Name	Time	Method
Healthcare Utilization	through study completion, an average of 2 years	Number of ERCPs, Radiological studies etc needed before accurate diagnosis

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States