Endoscopy 2023; 55(09): 796-803
DOI: 10.1055/a-2041-7687
Original article

Multicenter randomized trial comparing diagnostic sensitivity and cellular abundance with aggressive versus standard biliary brushing for bile duct stenosis without mass syndrome

1   Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, France
Jocelyn Privat
2   Digestive Endoscopy Unit, Vichy Hospital Center, Vichy, France
Aurélie Charissoux
3   Department of Pathology, University Hospital Centre of Limoges, Limoges, France
Bastien Perrot
4   UMR 1246 SPHERE (MethodS in Patient-centered outcomes and HEalth ResEarch), INSERM, Nantes University, Tours University, France
Sarah Leblanc
5   Digestive Endoscopy Unit, Jean Mermoz Private Hospital, Lyon, France
Ulriikka Chaput
6   Department of Digestive Diseases, Hôpital Saint-Antoine, Paris, France
Isabelle Boytchev
7   Gastroenterology Department, Le Kremlin-Bicêtre University Hospital, Le Kremlin-Bicêtre, France
Jonathan Levy
8   Digestive Endoscopy Unit, Clinique des Cèdres, Cornebarrieu, France
Marion Schaefer
 9   Hepatogastroenterology, Centre Hospitalier Universitaire de Nancy, Vandoeuvre les Nancy, France
Jean-François Bourgaux
10   Gastroenterology, Centre Hospitalier Universitaire Carémeau, Nîmes, France
Jean-Christophe Valats
11   Hepatogastroenterology, Hôpital Saint-Eloi, Montpellier, France
Emmanuel Coron
12   Digestive Diseases Institute, Centre Hospitalier Universitaire de Nantes, Nantes, France
13   Department of Gastroenterology and Hepatology, Geneva University Hospital (HUG), Geneva, Switzerland
Maira Moreno-Garcia
14   Research and Development Unit, French Society of Digestive Endoscopy, Paris, France
15   Centre Hospitalier Universitaire de Nice, Pôle DIGi-TUNED, Endoscopie Digestive, Hôpital L’Archet 2, Nice, France
Gabriel Rahmi
16   Gastroenterology and Digestive Endoscopy, Hôpital Européen Georges Pompidou, Paris, France
16   Gastroenterology and Digestive Endoscopy, Hôpital Européen Georges Pompidou, Paris, France
Timothée Wallenhorst
17   Department of Endoscopy and Gastroenterology, University Hospital Centre Rennes, Rennes, France
› Author Affiliations
Trial Registration: ClinicalTrials.gov Registration number (trial ID): NCT04251013 Type of study: Prospective Multicenter Randomized Trial


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 (P = 0.10). Cellularity was rich in 31/51 cases (61 %) with the Infinity brush and in 10/51 cases (20 %) with the RX Cytology Brush (P < 0.001). In terms of quantification of cellularity, the Infinity brush strongly outperformed the RX Cytology Brush in 28/51 cases (55 %), while the RX Cytology Brush strongly outperformed the Infinity brush in 4/51 cases (8 %; P < 0.001).

Conclusions This randomized crossover trial showed that the Infinity brush is not significantly more effective than the RX Cytology Brush for biliary stenosis without mass syndrome in terms of sensitivity for cholangiocarcinoma diagnosis, but does offer a significantly higher abundance of cellularity.

Publication History

Received: 02 November 2022

Accepted after revision: 23 February 2023

Accepted Manuscript online:
27 February 2023

Article published online:
03 May 2023

© 2023. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

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