Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures
ConditionBiliary Stricture
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Age <18 years old
No indication that cholangioscopy will be performed during endoscopic retrograde cholangiopancreatography (ERCP)
Prisoner
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Patients undergoing cholangioscopy for evaluation biliary stricture
Trial outcomes
Primary outcomes
1
POC-CNN Model AUC
Area Under the Curve (AUC) analysis for POC-CNN for classification of malignant biliary stricture
Time frame
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
Time frame
Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov