The use of SPEctroscopy during Endoscopy for Detection of BiLIary Strictures

The use of SPEctroscopy during Endoscopy for Detection of BiLIary Strictures - SPEEDBLIS trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48022

Enrollment

Registered

2019-07-26

Start date

2019-10-30

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bile duct cancer biliary strictures

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
As this is a feasibility study, the main parameter is the (percentage of) cases in which SFR spectroscopy was possible to measure the reflectance during ERCP procedure.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results