Multicenter randomized trial comparing diagnostic sensitivity and cellular abundance with aggressive versus standard biliary brushing for bile duct stenosis without mass syndrome.
Journal
Endoscopy
ISSN: 1438-8812
Titre abrégé: Endoscopy
Pays: Germany
ID NLM: 0215166
Informations de publication
Date de publication:
09 2023
09 2023
Historique:
medline:
31
8
2023
pubmed:
28
2
2023
entrez:
27
2
2023
Statut:
ppublish
Résumé
BACKGROUND : The diagnosis of cholangiocarcinoma in patients with a biliary stricture without mass syndrome can be obtained by biliary brushing with a sensitivity of ~50 %. We performed a multicenter randomized crossover trial comparing the aggressive Infinity brush with the standard RX Cytology Brush. The aims were to compare sensitivity for cholangiocarcinoma diagnosis and cellularity obtained. METHODS : Biliary brushing was performed consecutively with each brush, in a randomized order. Cytological material was studied with blinding to the brush type used and order. The primary end point was sensitivity for cholangiocarcinoma diagnosis; the secondary end point was the abundance of cellularity obtained with each brush, with cellularity quantified in order to determine if one brush strongly outperformed the other. RESULTS : 51 patients were included. Final diagnoses were cholangiocarcinoma (n = 43; 84 %), benign (n = 7; 14 %), and indeterminate (n = 1; 2 %). Sensitivity for cholangiocarcinoma was 79 % (34 /43) for the Infinity brush versus 67 % (29/43) for the RX Cytology Brush (
Banques de données
ClinicalTrials.gov
['NCT04251013']
Types de publication
Randomized Controlled Trial
Multicenter Study
Clinical Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
796-803Informations de copyright
Thieme. All rights reserved.
Déclaration de conflit d'intérêts
D. Karsenti has received consulting fees from Olympus. J. Privat has received consulting fees from Boston Scientific. S. Leblanc has received consulting fees from Boston Scientific and Olympus, and is on the advisory board of Alfasigma and Norgine. J. Levy has received consulting fees from Ambu. M. Schaefer has received consulting fees from Boston Scientific, lecture fees from Ferring, Alfasigma and Duomed Endoscopy, and is on the advisory board of Abbvie. G. Vanbiervliet has received consulting fees from Ambu, Boston Scientific, Cook and Fujifilm, and lecture fees from Tillots Inc. Fujifilm, Boston Scientific and Pentax. G. Rahmi has received consulting fees from Medtronic and Fujifilm, and lecture fees from Boston Scientific and Pentax. E. Perez-Cuadrado Robles has received consulting fees from Boston Scientific. T. Wallenhorst has received consulting fees from Fujifilm and Olympus.The remaining authors declare that they have no conflict of interest.