The use of SPEctroscopy during Endoscopy for Detection of BiLIary Strictures

Completed

• Conditions: bile duct cancer; biliary strictures; 10019815; 10019818

• Registration Number: NL-OMON48022
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Patients scheduled for ERCP, due to indeterminate biliary strictures.

Exclusion Criteria

- Patients with age under 18 years
- Patients who object to participate in this study.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>As this is a feasibility study, the main parameter is the (percentage of) cases<br /><br>in which SFR spectroscopy was possible to measure the reflectance during ERCP<br /><br>procedure.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The shape of the spectra and the optical absorption coefficients over a broad<br /><br>wavelength range will be used to distinguish benign and malign biliary<br /><br>strictures. To extract and quantify physiological information from the obtained<br /><br>spectra validated mathematical model, based on the knowledge of the absorption<br /><br>spectra of the chromophores, will be used. The extracted parameters are:<br /><br>1) Microvascular saturation<br /><br>2) Blood volume<br /><br>3) Average vascular diameter<br /><br>4) Parameter related to the scattering properties of tissue in real-time.<br /><br><br /><br>The parameters will be linked to final histological analysis. </p><br>