In this randomized crossover trial involving patients with indeterminate biliary strictures, we aimed to compare the diagnostic performance of the dual-lumen catheter-guided miniforceps biopsy (CMB) device with that of brush cytology under aspiration (BCA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
112
In ERCP procedures, catheter-guided mini-forceps biopsy is performed before biliary brush cytology.
In ERCP procedures, biliary brush cytology with vacuum aspiration is performed before dilation catheter-guided mini-forceps biopsy.
Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China, China
The diagnostic accuracy
The accuracy of dual-lumen catheter-guided miniforceps biopsy (CMB) and brush cytology with vacuum aspiration (BCA) in the diagnosis of biliary strictures.
Time frame: 6 months
the diagnostic sensitivity
The diagnostic sensitivity of dual-lumen catheter-guided mini-forceps biopsy and brush cytology with vacuum aspiration to the suspicious biliary strictures.
Time frame: 6 months
The diagnostic specificity
The diagnostic specificity of dual-lumen catheter-guided mini-forceps biopsy and brush cytology with vacuum aspiration to the suspicious biliary strictures.
Time frame: 6 months
Severe adverse events rates
The incidence of adverse events, namely, post-ERCP pancreatitis, gastrointestinal perforation, and bleeding were compared.
Time frame: 6 months
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