Prospective Evaluation of Biliary Tissue Sampling with ERCP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2026-05-31

Brief Summary

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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

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Conditions

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Cholangiopancreatography, Endoscopic Retrograde Biliary Stricture Biliary Tract Diseases Cholangiocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

• Adults \<18 years, Children

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Vinay Chandrasekhara

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vinay Chandrasekhara, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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20-004079

Identifier Type: -

Identifier Source: org_study_id