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

NCT ID: NCT06964425

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-04

Study Completion Date

2025-07-30

Brief Summary

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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

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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

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

20 patients with known extrahepatic cholangiocarcinoma, over 18 years of age
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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patients with extrahepatic cholangiocarcinoma

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

Group Type EXPERIMENTAL

Endoscopic retrograde cholangiopancreatography (ERCP)

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* disagreement with the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Palacky University

OTHER

Sponsor Role collaborator

University Hospital Olomouc

OTHER

Sponsor Role lead

Responsible Party

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Peter Slodicka

Doctor of Medicine, Clinical Doctor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Slodička, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Olomouc

Locations

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Peter Slodička

Olomouc, Olomoucký kraj, Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Peter Slodička, M.D.

Role: CONTACT

+420776807612

Václav Ranc, Assoc. Prof.

Role: CONTACT

+420732834753

Facility Contacts

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Peter Slodička

Role: primary

776807612

References

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Slodicka P, Falt P, Ranc V, Zoundjiekpon VD, Urban O. Raman spectroscopy in the diagnosis of malignant biliary stricture: A feasibility study. Hepatobiliary Pancreat Dis Int. 2025 Apr;24(2):211-216. doi: 10.1016/j.hbpd.2024.11.003. Epub 2024 Nov 16. No abstract available.

Reference Type BACKGROUND
PMID: 39603958 (View on PubMed)

Other Identifiers

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UHO005

Identifier Type: -

Identifier Source: org_study_id

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