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NCT Number: NCT06964425

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

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.

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Key information

Conditions

Cholangiocarcinoma, Extrahepatic Adenocarcinoma Biliary Stricture Carcinoma Cholangiocarcinoma Cholangiocarcinoma of the Extrahepatic Bile Duct Cholangiocarcinoma, Perihilar Diagnosis Disease Endoscopy Klatskin Tumor Malignant Biliary Stricture Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Raman Spectroscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peter Slodička

Olomouc, Olomouc Region, 77900, Czechia

Location status: Recruiting

Location contact

Peter Slodička

CONTACT

[email protected]

776807612

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • disagreement with the study

Treatment and study plan

Endoscopic Retrograde Cholangiopancreatography (ERCP)

Procedure

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.

Primary outcomes

  1. The differences in Raman spectra of malignant biliary tissue compared to healthy biliary tissue

    Time frame: Perioperative/Periprocedural

    During single ERCP procedure, we take 20 measurements of the Raman spectra (10 from malignant biliary tissue and 10 from healthy biliary tissue) that each tissue emits after interaction with the laser light. We are interested in the specific difference in the spectra of each tissue, which will be shown as a two-dimensional curve. The differences in the spectra of each tissue will be reflected by a change in the shape of the curve.

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Slodička, M.D.

CONTACT

[email protected]

+420776807612

Václav Ranc, Assoc. Prof.

CONTACT

[email protected]

+420732834753

Sponsors and collaborators

Lead sponsor

University Hospital Olomouc

Other

Collaborators

  • Palacky University

Registry information

Official study title

Raman Spectroscopy in the Diagnosis of Extrahepatic Cholangiocarcinoma

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 9, 2025
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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