Cholangiocarcinoma, ExtrahepaticNCT06964425
Raman Spectroscopy in the Diagnosis of Extrahepatic Cholangiocarcinoma - a Pilot Study
A study testing Endoscopic retrograde cholangiopancreatography (ERCP) in people with Cholangiocarcinoma, Extrahepatic and Cholangiocarcinoma of the Extrahepatic Bile Duct, run by University Hospital Olomouc at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Extrahepatic, Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma, Perihilar
- What is being tested?
- Endoscopic retrograde cholangiopancreatography (ERCP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 4 Feb 2023to 30 Jul 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- person older than 18 years, who has known extrahepatic cholangiocarcinoma and is indicated for ERCP
Who cannot join
- disagreement with the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Peter Slodička
Olomouc, Olomouc Region, 77900
Peter Slodička, 776807612, peter.slodicka@fnol.cz
About this study
Official title: Raman Spectroscopy in the Diagnosis of Extrahepatic Cholangiocarcinoma
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.
Read the 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.
- Conditions
- Cholangiocarcinoma, Extrahepatic, Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma, Perihilar, Diagnosis, Raman Spectroscopy, Klatskin Tumor
- Being tested
- Endoscopic retrograde cholangiopancreatography (ERCP)
- Medical subject headings
- Cholangiocarcinoma, Klatskin Tumor, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic retrograde cholangiopancreatography (ERCP)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| patients with extrahepatic cholangiocarcinoma | Experimental | 20 patients with known cholangiocarcinoma indicated for endoscopic retrograde cholangiopancreatography over 18 years of age Receives: Procedure: Endoscopic retrograde cholangiopancreatography (ERCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differences in Raman spectra of malignant biliary tissue compared to healthy biliary tissue
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.
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start4 Feb 2023
- Primary completion31 May 2025
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholangiocarcinoma, ExtrahepaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 20 patients with known extrahepatic cholangiocarcinoma, over 18 years of age
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Collaborators
- Palacky University
- Responsible party
- Principal investigator, Peter Slodicka, University Hospital Olomouc
- Investigators
- Peter Slodička, M.D., Principal investigator, University Hospital Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964425
- Sponsor's protocol ID
- UHO005
- Status last verified
- Jun 2025
- First submitted
- 15 Apr 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39603958