NCT06964425

Raman Spectroscopy in the Diagnosis of Extrahepatic Cholangiocarcinoma - a Pilot Study

Raman Spectroscopy in the Diagnosis of Extrahepatic Cholangiocarcinoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University Hospital Olomouc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Diagnosis of extrahepatic cholangiocarcinoma is challenging because the yield of imaging and tissue sampling is limited. Raman spectroscopy is an optical method based on the analysis of scattered monochromatic light. Raman spectroscopy is able to provide a molecular 'fingerprint' of the tissue to determine its type. The aim of this pilot study was to develop a methodology for in vivo Raman spectroscopy in bile ducts to improve the current diagnostic capabilities of extrahepatic cholangiocarcinoma.

Detailed description

During ERCP, a fibre Raman probe (Endoscopic Fiber-Optic Raman Probe Bundle Fiber, Uni-Export Instruments, USA) is introduced transpapillary into the known extrahepatic cholangiocarcinoma. The Raman probe is placed in an adequate position under fluoroscopy control. Raman spectroscopy measurements are performed (without fluoroscopy) 20 times for each patient (laser wavelength 785 nm), 10 times for extrahepatic cholangiocarcinoma and 10 times for healthy bile duct. The attained data are saved and analysed by a specialised biophysicist. All patients provided informed consent.

Conditions

• Cholangiocarcinoma, Extrahepatic
• Cholangiocarcinoma of the Extrahepatic Bile Duct
• Cholangiocarcinoma, Perihilar
• Diagnosis
• Raman Spectroscopy
• Klatskin Tumor
• Endoscopy
• Biliary Stricture
• Malignant Biliary Stricture

Interventions

Type	Name	Description
PROCEDURE	Endoscopic retrograde cholangiopancreatography (ERCP)	Insertion of a endoscopic fiber-optic Raman probe under fluoroscopic control during endoscopic retrograde cholangiopancreatography to measure Raman spectra of extrahepatic cholangiocarcinoma and healthy bile duct.

Timeline

• Start date: 2023-02-04
• Primary completion: 2025-05-31
• Completion: 2025-07-30
• First posted: 2025-05-09
• Last updated: 2025-07-02

Locations

1 site across 1 country: Czechia