Comparison of Dual-lumen Catheter-guided Mini-forceps Biopsy and Brush Cytology with Vacuum Aspiration in Suspicious Biliary Strictures

Not Applicable

Completed

• Conditions: Endoscopic Retrograde Cholangiopancreatography (ERCP); Miniforceps Biopsy; Biliary Strictures; Brush Cytology
• Interventions: Procedure: Dual-lumen catheter-guided mini-forceps biopsy is performed first; Procedure: Biliary brush cytology with vacuum aspiration is performed first

• Registration Number: NCT06612931
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Primary Completion: 2024-07-20
• Status Verified: 2024-08
• Study Completion: 2024-08-16
• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-23
• Last Update Submitted: 2024-09-23
• Study First Posted: 2024-09-25
• Last Update Posted: 2024-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CMB	Dual-lumen catheter-guided mini-forceps biopsy is performed first	In ERCP procedures, catheter-guided mini-forceps biopsy (CMB) is performed before biliary brush cytology with vacuum aspiration (BCA).
BCA	Biliary brush cytology with vacuum aspiration is performed first	In ERCP procedures, biliary brush cytology with vacuum aspiration (BCA) is performed before dilation catheter-guided mini-forceps biopsy (CMB).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China