Prospective Evaluation of Biliary Tissue Sampling With ERCP

NCT04572711 | Completed Results

• 1 other identifier: 20-004079
• Study Type: observational
• Target: 327
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiopancreatography, Endoscopic Retrograde; Biliary Stricture; Biliary Tract Diseases; Cholangiocarcinoma

Outcome Measures

Primary Outcomes (3)

• 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.

  1 year after ERCP procedure

• Number of Adverse Events

  Adverse events after biliary sampling

  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.

  1 year after ERCP procedure

Secondary Outcomes (1)

• Healthcare Utilization

  through study completion, an average of 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Biliary Tract Diseases; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Vinay Chandrasekhara
• Organization: Mayo Clinic

chandrasekhara.vinay@mayo.edu

5072842511

Study Officials

• Vinay Chandrasekhara, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: October 1, 2020
• Primary Completion: December 18, 2024
• Study Completion: January 2, 2025
• Last Updated: May 22, 2026
• Results First Posted: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)