Biliary Strictures, Brush Cytology, Endoscopic Retrograde Cholangiopancreatography (ERCP), Miniforceps Biopsy
Conditions
Brief summary
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).
Interventions
PROCEDUREDual-lumen catheter-guided mini-forceps biopsy is performed first
In ERCP procedures, catheter-guided mini-forceps biopsy is performed before biliary brush cytology.
PROCEDUREBiliary brush cytology with vacuum aspiration is performed first
In ERCP procedures, biliary brush cytology with vacuum aspiration is performed before dilation catheter-guided mini-forceps biopsy.
Sponsors
Xijing Hospital of Digestive Diseases
Eastern Hepatobiliary Surgery Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 88 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 18-88 years old. * Willing and able to comply with the study procedures and provide written informed consent to participate in the study. * Biliary obstructive symptoms,or indeterminate biliary stricture suspected to be intrinsic based on prior imaging.
Exclusion criteria
* Any contraindications to ERCP. * Severe cardiopulmonary disease or coagulopathy. * Biliary strictures caused by extrinsic compression. * Unwillingness or inability to provide consent. * Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The diagnostic accuracy | 6 months | The accuracy of dual-lumen catheter-guided miniforceps biopsy (CMB) and brush cytology with vacuum aspiration (BCA) in the diagnosis of biliary strictures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the diagnostic sensitivity | 6 months | The diagnostic sensitivity of dual-lumen catheter-guided mini-forceps biopsy and brush cytology with vacuum aspiration to the suspicious biliary strictures. |
| The diagnostic specificity | 6 months | The diagnostic specificity of dual-lumen catheter-guided mini-forceps biopsy and brush cytology with vacuum aspiration to the suspicious biliary strictures. |
| Severe adverse events rates | 6 months | The incidence of adverse events, namely, post-ERCP pancreatitis, gastrointestinal perforation, and bleeding were compared. |
Countries
China
Outcome results
None listed