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
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 (

Identifiants

pubmed: 36849106
doi: 10.1055/a-2041-7687
doi:

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

796-803

Informations 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.

Auteurs

David Karsenti (D)

Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, France.

Jocelyn Privat (J)

Digestive Endoscopy Unit, Vichy Hospital Center, Vichy, France.

Aurélie Charissoux (A)

Department of Pathology, University Hospital Centre of Limoges, Limoges, France.

Bastien Perrot (B)

UMR 1246 SPHERE (MethodS in Patient-centered outcomes and HEalth ResEarch), INSERM, Nantes University, Tours University, France.

Sarah Leblanc (S)

Digestive Endoscopy Unit, Jean Mermoz Private Hospital, Lyon, France.

Ulriikka Chaput (U)

Department of Digestive Diseases, Hôpital Saint-Antoine, Paris, France.

Isabelle Boytchev (I)

Gastroenterology Department, Le Kremlin-Bicêtre University Hospital, Le Kremlin-Bicêtre, France.

Jonathan Levy (J)

Digestive Endoscopy Unit, Clinique des Cèdres, Cornebarrieu, France.

Marion Schaefer (M)

Hepatogastroenterology, Centre Hospitalier Universitaire de Nancy, Vandoeuvre les Nancy, France.

Jean-François Bourgaux (JF)

Gastroenterology, Centre Hospitalier Universitaire Carémeau, Nîmes, France.

Jean-Christophe Valats (JC)

Hepatogastroenterology, Hôpital Saint-Eloi, Montpellier, France.

Emmanuel Coron (E)

Digestive Diseases Institute, Centre Hospitalier Universitaire de Nantes, Nantes, France.
Department of Gastroenterology and Hepatology, Geneva University Hospital (HUG), Geneva, Switzerland.

Maira Moreno-Garcia (M)

Research and Development Unit, French Society of Digestive Endoscopy, Paris, France.

Geoffroy Vanbiervliet (G)

Centre Hospitalier Universitaire de Nice, Pôle DIGi-TUNED, Endoscopie Digestive, Hôpital L'Archet 2, Nice, France.

Gabriel Rahmi (G)

Gastroenterology and Digestive Endoscopy, Hôpital Européen Georges Pompidou, Paris, France.

Enrique Perez-Cuadrado Robles (EP)

Gastroenterology and Digestive Endoscopy, Hôpital Européen Georges Pompidou, Paris, France.

Timothée Wallenhorst (T)

Department of Endoscopy and Gastroenterology, University Hospital Centre Rennes, Rennes, France.

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Classifications MeSH