Biliary StrictureNCT05779436
Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures
An observational study of Biliary Stricture, run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this study is to demonstrate the feasibility and validity of a previously developed peroral cholangioscopy (POC) convolutional neural network (CNN) to determine the etiology of biliary strictures when used in real-time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Stricture
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2023to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with biliary strictures who are undergoing peroral cholangioscopy (POC) during endoscopic retrograde cholangiopancreatography (ERCP) for the evaluation of a biliary strictures will be identified via review of procedure listings at Mayo Clinic Rochester, Minnesota.
Who may be able to join
- Age ≥ 18 years old
- Anticipation that patient may undergo POC during an endoscopic retrograde cholangioscopy
- Pregnant patients can be included in the study. Use of the POC-CNN does not convey any new risk to the patient nor fetus.
- Non-English speaking subjects will be included in the study. Consent for the procedure itself is always done with the assistance of an interpreter via telephone or video. Use of the POC-CNN will be discussed with all patients via this interpreter during the procedure consent.
Who cannot join
- Age <18 years old
- No indication that cholangioscopy will be performed during endoscopic retrograde cholangiopancreatography (ERCP)
- Prisoner
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
Vinay Chandrasekhara, MD, 5077742687, chandrasekhara.vinay@mayo.edu
- Recruiting
University of Massachusetts
Worcester, Massachusetts, 01655
Neil Marya, (508) 334-3068, neil.marya@umassmemorial.org
About this study
The purpose of this study is to demonstrate the feasibility and validity of a previously developed peroral cholangioscopy (POC) convolutional neural network (CNN) to determine the etiology of biliary strictures when used in real-time.
- Conditions
- Biliary Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing cholangioscopy for evaluation biliary stricture | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
POC-CNN Model AUC
Area Under the Curve (AUC) analysis for POC-CNN for classification of malignant biliary stricture
Measured: Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology.
Secondary outcomes (1)
Test characteristics of POC-CNN
Sensitivity and Specificity of POC-CNN for the diagnosis of malignant biliary stricture, Sensitivity and Specificity of biliary brushings and biliary biopsies
Measured: Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start1 Apr 2023
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biliary StrictureStudies 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
- 100 participants (estimated)
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
- NCT05779436
- Sponsor's protocol ID
- 23-000450
- Status last verified
- Apr 2026
- First submitted
- 9 Mar 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marya NB, Powers PD, Marcello M, Rau P, Nasser-Ghodsi N, Marshall C, Zivny J, AbiMansour JP, Chandrasekhara V. Classification of Biliary Strictures Using Real-Time Cholangioscopy Artificial Intelligence: The SMART-AI Trial. Clin Gastroenterol Hepatol. 2026 Apr 9:S1542-3565(26)00245-4. doi: 10.1016/j.cgh.2026.03.033. Online ahead of print.
PubMed 41966465
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures
- ClinicalTrials.gov ID
- NCT05779436
- Acronym / sponsor ID
- 23-000450
- Conditions
- Biliary Stricture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
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 demonstrate the feasibility and validity of a previously developed peroral cholangioscopy (POC) convolutional neural network (CNN) to determine the etiology of biliary strictures when used in real-time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing cholangioscopy for evaluation biliary stricture | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with biliary strictures who are undergoing peroral cholangioscopy (POC) during endoscopic retrograde cholangiopancreatography (ERCP) for the evaluation of a biliary strictures will be identified via review of procedure listings at Mayo Clinic Rochester, Minnesota.
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Anticipation that patient may undergo POC during an endoscopic retrograde cholangioscopy
- Pregnant patients can be included in the study. Use of the POC-CNN does not convey any new risk to the patient nor fetus.
- Non-English speaking subjects will be included in the study. Consent for the procedure itself is always done with the assistance of an interpreter via telephone or video. Use of the POC-CNN will be discussed with all patients via this interpreter during the procedure consent.
Key exclusion criteria (3 listed)
- Age <18 years old
- No indication that cholangioscopy will be performed during endoscopic retrograde cholangiopancreatography (ERCP)
- Prisoner
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
POC-CNN Model AUC
Time frame: Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology.
Area Under the Curve (AUC) analysis for POC-CNN for classification of malignant biliary stricture
1 secondary outcome
Test characteristics of POC-CNN
Time frame: Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 41966465Marya NB, Powers PD, Marcello M, Rau P, Nasser-Ghodsi N, Marshall C, Zivny J, AbiMansour JP, Chandrasekhara V. Classification of Biliary Strictures Using Real-Time Cholangioscopy Artificial Intelligence: The SMART-AI Trial. Clin Gastroenterol Hepatol. 2026 Apr 9:S1542-3565(26)00245-4. doi: 10.1016/j.cgh.2026.03.033. Online ahead of print.
- 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.
Vinay Chandrasekhara, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Stricture, run by Mayo Clinic at 2 sites 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 1 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 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liz Lemke (507-284-2511, lemke.elizabeth@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POC-CNN Model AUC (time frame: Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology.). 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 NCT05779436, 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 1 May 2026.