Comparison of Dual-lumen Catheter-guided Mini-forceps Biopsy and Brush Cytology with Vacuum Aspiration in Suspicious Biliary Strictures
NCT ID: NCT06612931
Last Updated: 2024-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
112 participants
INTERVENTIONAL
2023-04-01
2024-08-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
DOUBLE
Study Groups
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CMB
In ERCP procedures, catheter-guided mini-forceps biopsy (CMB) is performed before biliary brush cytology with vacuum aspiration (BCA).
Dual-lumen catheter-guided mini-forceps biopsy is performed first
In ERCP procedures, catheter-guided mini-forceps biopsy is performed before biliary brush cytology.
BCA
In ERCP procedures, biliary brush cytology with vacuum aspiration (BCA) is performed before dilation catheter-guided mini-forceps biopsy (CMB).
Biliary 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.
Interventions
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Dual-lumen catheter-guided mini-forceps biopsy is performed first
In ERCP procedures, catheter-guided mini-forceps biopsy is performed before biliary brush cytology.
Biliary 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Severe cardiopulmonary disease or coagulopathy.
* Biliary strictures caused by extrinsic compression.
* Unwillingness or inability to provide consent.
* Pregnant or breastfeeding women.
18 Years
88 Years
ALL
No
Sponsors
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Xijing Hospital of Digestive Diseases
OTHER
Eastern Hepatobiliary Surgery Hospital
OTHER
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Baiwen Li
Director of the Gastrointestinal Endoscopy Center
Principal Investigators
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Baiwen Li, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine
Locations
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Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China, China
Countries
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Other Identifiers
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2022108
Identifier Type: -
Identifier Source: org_study_id
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