TY - JOUR
T1 - Comparison of two intraductal brush cytology devices for suspected malignant biliary strictures
T2 - randomized controlled trial
AU - Gorris, Myrte
AU - van Huijgevoort, Nadine C. M.
AU - Fockens, Paul
AU - Meijer, Sybren L.
AU - Verheij, Joanne
AU - Voermans, Rogier P.
AU - van Wanrooij, Roy L. J.
AU - Lekkerkerker, Selma J.
AU - van Hooft, Jeanin E.
N1 - Funding Information: We would like to acknowledge and thank the members of the data safety monitoring board (Robert C. Verdonk [chair; Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands], Lydi M.J.W. van Driel [Department of Gastroenterology and Hepatology Erasmus Medical Center, Rotterdam, the Netherlands], and Susan van Dieren [Department of Surgery, Amsterdam UMC, Amsterdam, the Netherlands], for their kind participation and critical evaluation of our study data. Publisher Copyright: © 2023, The Author(s).
PY - 2023/6
Y1 - 2023/6
N2 - Background: Endoscopic retrograde cholangiopancreatography (ERCP) with biliary brush cytology is commonly used to diagnose malignant pancreatobiliary strictures. This trial compared the sensitivity of two intraductal brush cytology devices. Methods: A randomized controlled trial in which consecutive patients with suspected malignant, extrahepatic biliary strictures were randomized (1:1) to a dense or conventional brush cytology device. Primary endpoint was sensitivity. Interim analysis was conducted after 50% of the patients completed follow-up. Results were interpreted by a data safety monitoring board. Results: Between June 2016 and June 2021, 64 patients were randomized to the dense (27 patients, 42%) or conventional brush (37 patients, 58%). Malignancy was diagnosed in 60 patients (94%) and benign disease in 4 patients (6%). Diagnoses were confirmed by histopathology in 34 patients (53%), cytopathology in 24 patients (38%), and clinical or radiological follow up in 6 patients (9%). Sensitivity of the dense brush was 50%, compared to 44% for the conventional brush (p = 0·785). Discussion: The results of this randomized controlled trial showed that the sensitivity of a dense brush is not superior to a conventional brush for diagnosing malignant extrahepatic pancreatobiliary strictures. This trial was prematurely ended for reasons of futility. Trial registration: Netherlands Trial Register number; NTR5458.
AB - Background: Endoscopic retrograde cholangiopancreatography (ERCP) with biliary brush cytology is commonly used to diagnose malignant pancreatobiliary strictures. This trial compared the sensitivity of two intraductal brush cytology devices. Methods: A randomized controlled trial in which consecutive patients with suspected malignant, extrahepatic biliary strictures were randomized (1:1) to a dense or conventional brush cytology device. Primary endpoint was sensitivity. Interim analysis was conducted after 50% of the patients completed follow-up. Results were interpreted by a data safety monitoring board. Results: Between June 2016 and June 2021, 64 patients were randomized to the dense (27 patients, 42%) or conventional brush (37 patients, 58%). Malignancy was diagnosed in 60 patients (94%) and benign disease in 4 patients (6%). Diagnoses were confirmed by histopathology in 34 patients (53%), cytopathology in 24 patients (38%), and clinical or radiological follow up in 6 patients (9%). Sensitivity of the dense brush was 50%, compared to 44% for the conventional brush (p = 0·785). Discussion: The results of this randomized controlled trial showed that the sensitivity of a dense brush is not superior to a conventional brush for diagnosing malignant extrahepatic pancreatobiliary strictures. This trial was prematurely ended for reasons of futility. Trial registration: Netherlands Trial Register number; NTR5458.
KW - Bile Duct Neoplasms/complications
KW - Biliary Tract
KW - Biliary tract neoplasms
KW - Cholangiopancreatography, Endoscopic Retrograde
KW - Cholestasis/etiology
KW - Clinical pathology
KW - Constriction, Pathologic/etiology
KW - Endoscopic retrograde cholangiopancreatography
KW - Humans
KW - Pancreatic Neoplasms/complications
KW - Pancreatic neoplasms
KW - Sensitivity
KW - Sensitivity and Specificity
KW - Specificity
UR - http://www.scopus.com/inward/record.url?scp=85148954658&partnerID=8YFLogxK
U2 - https://doi.org/10.1007/s00464-023-09916-9
DO - https://doi.org/10.1007/s00464-023-09916-9
M3 - Article
C2 - 36849566
SN - 0930-2794
VL - 37
SP - 4566
EP - 4573
JO - Surgical endoscopy
JF - Surgical endoscopy
IS - 6
ER -