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

NCT06964425 | Recruiting

• 1 other identifier: UHO005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Perioperative/Periprocedural

Study Arms (1)

patients with extrahepatic cholangiocarcinoma

EXPERIMENTAL

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

Procedure: Endoscopic retrograde cholangiopancreatography (ERCP)

Interventions

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.

patients with extrahepatic cholangiocarcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• disagreement with the study

Sponsors & Collaborators

• University Hospital Olomouc: lead
• Palacky University: collaborator

Study Sites (1)

Peter Slodička

Olomouc, Olomoucký kraj, 77900, Czechia

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Cholangiocarcinoma; Klatskin Tumor; Disease

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Peter Slodička, M.D.

  University Hospital Olomouc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Slodička, M.D.

CONTACT

+420776807612; peter.slodicka@fnol.cz

Václav Ranc, Assoc. Prof.

CONTACT

+420732834753; vaclav.ranc@upol.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine, Clinical Doctor, Principal Investigator

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

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 9, 2025
• Study Start: February 4, 2023
• Primary Completion: May 31, 2025
• Study Completion: July 30, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)