K83
Conditions
Interventions
Group 1: Collection and analysis of data from a routine diagnostic transpapillary cholangioscopy performed once by usage of the SpyGlassDS cholangioscope within the scope of a clinically indicated end
Sponsors
Klinik für Gastroenterologie und Hepatologie, Universitätsklinikum Essen (AöR)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: -- Patients with indeterminate bile duct strictures suggested by imaging methods (US/CT/MRI/EUS/ERC), who have not undergone cholangioscopy before. -- Patients of legal capacity aged 18 years and older. -- in- and outpatient command of written and spoken German. -- written informed consent after information on study and data protection.
Exclusion criteria
Exclusion criteria: -- participation in this study at an earlier date. -- deviation from standard execution of ERCP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity for neoplastic biliary strictures, gained from visual impressions by "SpyDS" cholangioscopy | — |
Secondary
| Measure | Time frame |
|---|---|
| -- Definition of appropriate visual key criteria and samples for the evaluation of malignant and non-malignant changes of bilary strictures. -- Development of a diagnostic algorithm for indeterminate stric-ture evaluation by “SpyDs” cholangioscopy. -- Development of a set of imaging criteria location-independent usable for differential diagnosis of biliary strictures using the SpyDS cholangioscope. -- Identification of additional characteristics (accuracy / positive predictive value (PPV) / negative predictive value (NPV). -- Determination of inter-observer variability in the differential diagnosis of biliary strictures by SpyGlassDS-cholangioscopy. | — |
Countries
Germany
Contacts
Public ContactChristian Lange
Klinik für Gastroenterologie und Hepatologie, Universitätsklinikum Essen (AöR)
Outcome results
None listed