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| Name | Class |
|---|---|
| Xijing Hospital of Digestive Diseases | OTHER |
| Eastern Hepatobiliary Surgery Hospital | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMB | Experimental | In ERCP procedures, catheter-guided mini-forceps biopsy (CMB) is performed before biliary brush cytology with vacuum aspiration (BCA). |
|
| BCA | Active Comparator | In ERCP procedures, biliary brush cytology with vacuum aspiration (BCA) is performed before dilation catheter-guided mini-forceps biopsy (CMB). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-lumen catheter-guided mini-forceps biopsy is performed first | Procedure | In ERCP procedures, catheter-guided mini-forceps biopsy is performed before biliary brush cytology. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| The diagnostic specificity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Baiwen Li, Ph.D. | Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | China | 201620 | China |
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| Biliary brush cytology with vacuum aspiration is performed first | Procedure | In ERCP procedures, biliary brush cytology with vacuum aspiration is performed before dilation catheter-guided mini-forceps biopsy. |
|
The diagnostic specificity of dual-lumen catheter-guided mini-forceps biopsy and brush cytology with vacuum aspiration to the suspicious biliary strictures.
| 6 months |
| Severe adverse events rates | The incidence of adverse events, namely, post-ERCP pancreatitis, gastrointestinal perforation, and bleeding were compared. | 6 months |