Cholangiopancreatography, Endoscopic RetrogradeNCT04572711
Prospective Evaluation of Biliary Tissue Sampling With ERCP
An observational study of Cholangiopancreatography, Endoscopic Retrograde and Biliary Stricture, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiopancreatography, Endoscopic Retrograde, Biliary Stricture, Biliary Tract Diseases
- How many people
- 327 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 2 Jan 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults > 18 years
- Diagnosis of indeterminate biliary stricture
- Scheduled clinically indicated ERCP procedure
Who cannot join
- Adults <18 years, Children
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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
- Medical subject headings
- Biliary Tract Diseases, Cholangiocarcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after ERCP procedure
Number of Adverse Events
Adverse events after biliary sampling
Measured: 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.
Measured: 1 year after ERCP procedure
Secondary outcomes (1)
Healthcare Utilization
Number of ERCPs, Radiological studies etc needed before accurate diagnosis
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Oct 2020
- Primary completion18 Dec 2024
- Study completion2 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholangiopancreatography, Endoscopic RetrogradeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vinay Chandrasekhara, Mayo Clinic
- Investigators
- Vinay Chandrasekhara, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572711
- Sponsor's protocol ID
- 20-004079
- Status last verified
- Apr 2026
- First submitted
- 9 Sep 2020
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aggarwal M, Gores GJ, Vargas EJ, Storm AC, Law RJ, Abu Dayyeh BK, Martin JA, Petersen BT, Eaton JE, Ilyas SI, Roberts LR, Chandrasekhara V. The incidence and predictors of false-negative pancreatobiliary fluorescence in situ hybridization (PB-FISH) in biliary strictures: A prospective study. Hepatol Commun. 2025 Jul 21;9(8):e0751. doi: 10.1097/HC9.0000000000000751. eCollection 2025 Aug 1.
PubMed 40689505
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Biliary Tissue Sampling With ERCP
- ClinicalTrials.gov ID
- NCT04572711
- Acronym / sponsor ID
- 20-004079
- Conditions
- Cholangiopancreatography, Endoscopic Retrograde, Biliary Stricture, Biliary Tract Diseases, Cholangiocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 2 Jan 2025 (actual)
- First posted
- 1 Oct 2020 (actual)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adults > 18 years
- Diagnosis of indeterminate biliary stricture
- Scheduled clinically indicated ERCP procedure
Key exclusion criteria (1 listed)
- Adults <18 years, Children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Number of Adverse Events
Time frame: Within 30 days of ERCP procedure
Adverse events after biliary sampling
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.
1 secondary outcome
Healthcare Utilization
Time frame: through study completion, an average of 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40689505Aggarwal M, Gores GJ, Vargas EJ, Storm AC, Law RJ, Abu Dayyeh BK, Martin JA, Petersen BT, Eaton JE, Ilyas SI, Roberts LR, Chandrasekhara V. The incidence and predictors of false-negative pancreatobiliary fluorescence in situ hybridization (PB-FISH) in biliary strictures: A prospective study. Hepatol Commun. 2025 Jul 21;9(8):e0751. doi: 10.1097/HC9.0000000000000751. eCollection 2025 Aug 1.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinay Chandrasekhara, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiopancreatography, Endoscopic Retrograde and Biliary Stricture, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Characteristics (time frame: 1 year after ERCP procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04572711, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.