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

University Hospital Olomouc

Status: Enrolling

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

Treatments: Procedure: Endoscopic retrograde cholangiopancreatography (ERCP)

Study type: Interventional

Funder types: Other

Identifiers

NCT06964425

UHO005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• person older than 18 years, who has known extrahepatic cholangiocarcinoma and is indicated for ERCP

Exclusion criteria

• disagreement with the study

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

patients with extrahepatic cholangiocarcinoma

Experimental group

Description:

20 patients with known cholangiocarcinoma indicated for endoscopic retrograde cholangiopancreatography over 18 years of age

Treatment:

Procedure: Endoscopic retrograde cholangiopancreatography (ERCP)