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Recruiting NCT06964425

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

No phase Interventional Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma of the Extrahepatic Bile Duct Cholangiocarcinoma, Perihilar Diagnosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endoscopic retrograde cholangiopancreatography (ERCP).
Who it may be relevant to
Registry conditions: Cholangiocarcinoma, Extrahepatic, Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma, Perihilar, Diagnosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Raman Spectroscopy in the Diagnosis of Extrahepatic Cholangiocarcinoma

Overview

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

  • 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.

Primary outcome measures

  • The differences in Raman spectra of malignant biliary tissue compared to healthy biliary tissue [Time frame: Perioperative/Periprocedural]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • disagreement with the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Czechia · 1 center
  • Peter Slodička — Olomouc

Publications

  • 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. PMID 39603958

Identifiers

NCT: NCT06964425 · UHO005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗