Biliary Stricture
Conditions
Brief 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.
Interventions
None listed
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Age \<18 years old * No indication that cholangioscopy will be performed during endoscopic retrograde cholangiopancreatography (ERCP) * Prisoner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| POC-CNN Model AUC | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Test characteristics of POC-CNN | Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology. | Sensitivity and Specificity of POC-CNN for the diagnosis of malignant biliary stricture, Sensitivity and Specificity of biliary brushings and biliary biopsies |
Countries
United States
Contacts
CONTACTLiz Lemke
PRINCIPAL_INVESTIGATORVinay Chandrasekhara, MD
Mayo Clinic
Outcome results
None listed