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CC BY 4.0 · Endosc Int Open 2025; 13: a25698969
DOI: 10.1055/a-2569-8969
Original article

Contrast-enhanced vs. standard endoscopic ultrasound fine-needle aspiration for diagnosing malignant biliary tumors: Randomized controlled trial

Rares Ilie Orzan 
1   Gastroenterology, Regional Institute of Gastroenterology and Hepatology Prof Dr Octavian Fodor, Cluj-Napoca, Romania (Ringgold ID: RIN433709)
,
Sorana D. Bolboacă 
2   Medical Informatics and Biostatistics, Iuliu Hațieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (Ringgold ID: RIN37576)
,
Cristina Pojoga
3   Clinical Psychology and Psychotherapy, Babeș-Bolyai University, Cluj-Napoca, Romania
,
Claudia Hagiu
4   3rd Department of Internal Medicine, Iuliu Hațieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (Ringgold ID: RIN37576)
,
Ofelia Mosteanu
5   3rd Medical Clinic, University of Medicine and Pharmacy Cluj-Napoca, Cluj-Napoca, Romania
,
Ioana Rusu
4   3rd Department of Internal Medicine, Iuliu Hațieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (Ringgold ID: RIN37576)
,
Voicu Rednic
6   Regional Institute of Gastroenterology and Hepatology Prof Dr Octavian Fodor, Cluj-Napoca, Romania (Ringgold ID: RIN433709)
,
Radu Seicean
7   Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (Ringgold ID: RIN37576)
,
Nadim Al Hajjar
7   Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (Ringgold ID: RIN37576)
,
Renata Agoston
7   Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (Ringgold ID: RIN37576)
,
Andrada Seicean
8   Regional Institute of Gastroenterology and Hepatology, University of Medicine and Pharmacy, Cluj-Napoca, Romania
› Author Affiliations Clinical Trial: Registration number (trial ID): NCT05418543, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: Randomized
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Abstract

Background and study aims

Contrast-enhanced endoscopic ultrasound (CH-EUS) is superior to standard EUS for staging biliary duct tumors (BDTs), but its role in guiding EUS-guided fine needle aspiration (EUS-FNA) remains unclear. We compared diagnostic accuracy of CH-EUS-fine needle aspiration (CH-EUS-FNA) and standard EUS-FNA in patients with suspected malignant biliary stenosis.

Patients and methods

A parallel randomized controlled trial was conducted in a tertiary medical center and included jaundiced patients with suspected malignant biliary stenosis on computed tomography. The patients were assigned randomly to EUS-FNA or CH-EUS-FNA groups. Final diagnosis was determined based on EUS-FNA, surgical specimen results, endoscopic retrograde cholangiopancreatography (ERCP), or 12-month follow-up.

Results

Sixty-one patients were included in the study, 31 in the EUS-FNA group and 30 in the CH-EUS-FNA group. Mean age of participants was 74 ± 11.04 years and mean tumor size was 20.39 ± 9.17 mm, with 43 tumors in the distal bile duct. Final diagnoses were cholangiocarcinoma (37 cases), pancreatic ductal carcinoma (12 cases), other malignancies (3 cases), and benign lesion (9 cases). Diagnostic sensitivity, specificity, and accuracy were 83.3%, 100%, and 87.1% for EUS-FNA, and 82.1%, 100%, and 83.3% for CH-EUS-FNA. Plastic biliary stent placement and tumor location did not influence results. Hyperenhancement in the CH-EUS with rapid washout was observed in 90.9% of cholangiocarcinoma cases.

Conclusions

Standard EUS-FNA and CH-EUS-FNA demonstrated comparable diagnostic accuracy in evaluation of extrahepatic bile duct tumors, but with better slightly efficiency and inaccuracy indices than standard EUS-FNA.

Keywords

Endoscopic ultrasonography - Biliary tract - Fine-needle aspiration/biopsy - Tissue diagnosis

Supplementary Material



Publication History

Received: 31 December 2024

Accepted after revision: 24 February 2025

Article published online:
12 May 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).

Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

Bibliographical Record
Rares Ilie Orzan, Sorana D. Bolboacă, Cristina Pojoga, Claudia Hagiu, Ofelia Mosteanu, Ioana Rusu, Voicu Rednic, Radu Seicean, Nadim Al Hajjar, Renata Agoston, Andrada Seicean. Contrast-enhanced vs. standard endoscopic ultrasound fine-needle aspiration for diagnosing malignant biliary tumors: Randomized controlled trial. Endosc Int Open 2025; 13: a25698969.
DOI: 10.1055/a-2569-8969
 

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