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

Raman Spectroscopy in the Diagnosis of Extrahepatic Cholangiocarcinoma

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06964425
Enrollment
20
Registered
2025-05-09
Start date
2023-02-04
Completion date
2025-07-30
Last updated
2025-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

PROCEDUREEndoscopic 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.

Sponsors

Palacky University
CollaboratorOTHER
University Hospital Olomouc
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* disagreement with the study

Design outcomes

Primary

MeasureTime frameDescription
The differences in Raman spectra of malignant biliary tissue compared to healthy biliary tissuePerioperative/PeriproceduralDuring 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.

Countries

Czechia

Contacts

Primary ContactPeter Slodička, M.D.
peter.slodicka@fnol.cz+420776807612
Backup ContactVáclav Ranc, Assoc. Prof.
vaclav.ranc@upol.cz+420732834753

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026