NCT04572711

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

December 11, 2024

Status Verified

November 1, 2024

Enrollment Period

5.3 years

First QC Date

September 9, 2020

Last Update Submit

December 6, 2024

Conditions

Cholangiopancreatography, Endoscopic RetrogradeBiliary StrictureBiliary Tract DiseasesCholangiocarcinoma

Outcome Measures

Primary Outcomes (2)

  • Performance characteristics

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

    1 year after ERCP procedure

  • Number of adverse events

    Adverse events after biliary sampling

    Within 30 days of ERCP procedure

Secondary Outcomes (1)

  • Healthcare Utilization

    through study completion, an average of 2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults 18 years of age or older who are undergoing ERCP with tissue sampling for an indeterminate biliary stricture will be identified at the time of their scheduled procedure.

You may qualify if:

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

You may not qualify if:

  • Adults \<18 years, Children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Biliary Tract DiseasesCholangiocarcinoma

Condition Hierarchy (Ancestors)

Digestive System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Vinay Chandrasekhara, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 9, 2020

First Posted

October 1, 2020

Study Start

September 1, 2020

Primary Completion

December 1, 2025

Study Completion

May 1, 2026

Last Updated

December 11, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)