The use of SPEctroscopy during Endoscopy for Detection of PANcreatic Cancer

Recruiting

• Conditions: pancreas; pancreatic cancer; pancreatic lesions; 10027656

• Registration Number: NL-OMON50186
• 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: Recruiting
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

Patients scheduled for EUS-FNA, due to a suspect lesion of the pancreas

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>The shape of the spectra and the optical absorption coefficients over a broad<br /><br>wavelength range will be used to distinguish pancreatic tumors and benign<br /><br>pancreatic tissue. To extract and quantify physiological information from the<br /><br>obtained spectra, such as blood volume fraction and tissue oxygenation, a<br /><br>validated mathematical model, based on the knowledge of the absorption spectra<br /><br>of the chromophores, will be used. Therefore, we need to determine the serum<br /><br>bilirubin and hemoglobin, before the EUS-FNA is performed, which is part of<br /><br>the clinical workflow ('zorgpad pancreas'). The obtained spectra will be linked<br /><br>to final cytological analysis. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The diagnostic accuracy (including sensitivity, specificity, negative<br /><br>predictive value and positive predictive value) of one or more combined<br /><br>wavelengths specific for pancreatic tumor tissue will be calculated after<br /><br>comparison to cytological and final diagnosis.</p><br>